On the Urgent Medical Device Correction letter or postcard you received, please tell us your unique customer code. Removes the responsibility from the user. 1007257517. If you have any questions or concerns about this issue, contact Philips Service Delivery team on 1800 251 400. Just snap this new electrode pad cartridge into the Philips HeartStart OnSite, Home, or HS1 AED. To acknowledge receipt of this notification, please complete and return the Customer Reply Form by email or by fax by February 15, 2021. A08A-05842, A: No, it is not required to replace affected AEDs because when used in accordance with Instructions for Use and other labeling, including this recall/notification, the HS1/OnSite/Home and FRx devices are effective and safe to use. If your device is no longer under warranty, or if you desire to purchase a newer model replacement for your present AED, you may be eligible for a trade-in rebate. A: Yes. See example below. If you no longer own the AED, will you explain (for example: transferred to someone else, etc. Don't Be Caught Off Guard CLICK TO CHECK MULTIPLE SERIAL NUMBERS Check Now Note: If you need help accessing information in different file formats, see
for Recall. 55 Chastain Road NWSuite 112Kennesaw, GA 30144, If you have any question, please contact us at sales@aedbrands.com. This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Philips Electronics Australia Ltd, in consultation with the Therapeutic Goods Administration, is undertaking a Product Defection Correction to alert users to a possible problem with the AED SMART Pads used with these defibrillators. Bothell WA 98021-8431. Adds accountability and ensures readiness. Philips. A problem has been identified in certain philips m5072a heartstart infant/child smart pads cartridges (lot y111220-01) which are used with the philips heartstart onsite and heartstart home automated external defibrillators (aeds). Why is the Onsite AED backordered? This form consists of 4 pages. To respond to an issue, the manufacturer will compose a plan of action called a recall strategy. Connecting the infant/child SMART pads to the HeartStart OnSite AED also reduces the joule count from 150 Joules to 50 Joules. Q: Are the AEDs under this recall safe to use? If a device is covered by this notification and is still under warranty, you may optionally receive a refurbished exchange unit at no cost. Ray ID: 7ec46debe85708cc
Your answer to question 8 must be a valid email address. It will include specific instructions on what should be done regarding the AED. If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. The AED is both defective and a risk to health. In the United States, contact Philips directly at 1-800-263-3342. During use, ensure most of the pad surface is covered with gel and apply the pads to the patient. Medical Device Recall Notice - Certain AED's Serial Numbers Affected. Continue to use the HS1/OnSite/Home AED and pads as-is. Your report will contribute to the TGA's monitoring of these products. 2. 3. A08A-03450, A: No. ZOLL. DearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur HS1/OnSite/HomeAEDpads(PN:M5071A,M5072A)havebeenobservedtoexperiencegelseparationfromthe foam/tinbackingwhenpeele. Philips AED Recall THE PHILIPS ONSITE AED IS ON NATIONWIDE BACKORDER WITH AN UNKNOWN SHIP DATE. If you want to receive a follow-up reply, please include your name and e-mail address. Example: Yes, I would like to receive emails from Courtemanche & Associates. Lift out the used pads cartridge. A: Yes. An AED manufacturer will recall a device for a few reasons. Contact the manufacturer if you require additional information. Philips OnSite Infant Pads; Philips FRx Infant Key; ZOLL AED Pedi Padz; Cardiac Science G3 Pediatric Pads; Cardiac Science G5 Pediatric Pads; HeartSine AED Pediatric Pad-Pak; Must request for alternative languages. Koninklijke Philips N.V., 2004 - 2023. The problem is related to the graphic on the cover for the pads cartridge incorrectly showing application . Your email address will not be published. If you received a recall/notification letter from Philips, our records indicate you possess an affected device. Product Description Philips HeartStart Adult SMART Pads Cartridge is the replacement or spare pads for the Philips HeartStart Onsite, Home or HS1 series defibrillators. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Please answer question 10 before continuing. Philips FR2 AED Pads Adult $44.00 USD. Visit www.philips.com/aedaudiblechirps to hear an example. AEDs with high resistance to dust and water damage. For the best experience on our site, be sure to turn on Javascript in your browser. Manufacturer Reason. On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. A pediatric key or button eliminates the need to purchase pediatric pads. Completing this form confirms receipts of the Urgent Medical Device Correction . Philips has identified that for affected pads, some gel may fold onto itself, resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad to make contact with a patient's skin. See example below. If so, just fill our your email address below and submit. The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. The devices may continue to be used. If a device is no longer under warranty or if you wish to purchase a newer model replacement for their present AED, as an owner of a Philips HeartStart FRx, HS1 OnSite, or HS1 Home AED affected by this action, you may be eligible for a trade-in rebate. LIFEPAK Infant-Child AED Pads (All Models). Manufacturers are required to report to the FDA a correction or removal of a product if it involves a risk of health within ten working days of the recall. Your IP: 172.96.182.142. NOTE: This is not your order number or invoice number, this is a specific number assigned to you and is printed on your Medical Device Correction letter or postcard.If you do not have your unique customer code, please contact your local Philips Representative or call800-263-3342 and exit this survey. I am forwarding your question to our consulting team and will get the information you are requesting as soon as possible. 22100 Bothell Everett Highway, Bothell, Washington. A: No, it is not required to replace affected AEDs because when used in accordance with Instructions for Use and other labeling, including this recall/notification, the HS1/OnSite/Home and FRx devices are effective and safe to use. Prompts are repeated and rephrased if needed and include additional instructions to aid understanding. If you wish to confirm whether your device is affected and therefore potentially eligible for one of the warranty replacement or trade-in programs, please call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the . If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. Please answer question 8 before continuing. 2): M-F 9am - 6pm ESTSales (ext. A removal addresses the problem by removing the product from the field. Physio-Control. The problem is related to the graphic on the cover for the pads cartridge incorrectly showing application to an adult instead of a child. 6. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. The TGA cannot give advice about an individual's medical condition. JavaScript seems to be disabled in your browser. SO, WHAT DOES THAT REALLY MEAN? You can access the database for medical device recalls on the FDAs website. PHILIPS HEALTHCARE. Details The Philips HeartStart Infant/Child SMART Pads are for use on children 8-years-old and younger or with a weight less than 55lbs (including infants). There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. HEARTSTART DEFIBRILLATION PADS (2021-07-28). When the pads are connected to the HeartStart OnSite, the voice commands appropriately change for a pediatric rescue. Additional information . Q: Are the AEDs under this recall safe to use? The devices may continue to be used. Affected AEDs are not recommended to be removed from service. Remove a new SMART Pads Cartridge from its package and insert the cartridge into the cartridge well on the front of the HeartStart. RECERT Standard First Aid CPR Level BLS. A problem has been identified in certain philips m5072a heartstart infant/child smart pads cartridges (lot y111220-01) which are used with the philips heartstart onsite and heartstart home automated external defibrillators (aeds). If spare cartridges are unavailable, provide CPR until emergency medical services personnel arrive. Q: Are the affected AEDs being removed from service? While waiting to receive the replacement, customers should keep the Infant/Child . You can email the site owner to let them know you were blocked. Philips is offering trade-in rebates depending on the age and model of the affected AED. Reminder: Global supply chain shortages are causing significant industry-wide backorders, delaying the availability of AEDs and AED accessories. AEDs are classified as Class III medical devices; as such they are regulated by the Food and Drug Administration (FDA). If you do not receive a letter but are made aware of the recall to your AED device you should contact the manufacturer and follow their instructions. Heartstart Home Philips Electronics Australia Ltd, in consultation with the Therapeutic Goods Administration, is undertaking a Product Defection Correction to alert users to a possible problem with the AED SMART Pads used with these defibrillators. Customers were not notified of previous recalls associated with various defibrillator models. Philips HeartStart FRx AED with FREE Carry Case 861304, HeartSine Samaritan 350P/360P AED Defibrillator. Hi Lavonda. If your device is still under warranty, you are entitled to receive a refurbished exchange unit at no cost, in accordance with our standard warranty terms. This means the FDA monitors the safety and effectiveness of all AED devices and they have the power to enforce device recalls. Pads Recall - Landing Page Form. If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342. We are always looking for ways to improve our website. A: Yes. may be reported to the FDA s Med Watch Adverse Event Reporting program A07H-03121, Its important to keep your AED defibrillator in working condition in case of an SCA. Fully online knowledge-based class. URGENT MEDICAL DEVICE RESPONSE FORM. The serial number for HeartStart HS1, HeartStart Onsite and HeartStart Home starts with the letter A, followed by 8 numbers and letters. If an AED is recalled by the FDA it is important to adhere to the instructions that they provide in order to keep your AED safe and effective in case of an SCA event. The devices may continue to be used. Philips is offering trade-in rebates depending on the age and model of the affected AED. Please answer question 4 before continuing. The FDA also publishes a weekly FDA Enforcement Report where you can find all enforcement actions including recalls, field corrections, seizures, and injunctions. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency. 4): M-F 8am- 5pm ESTService (ext. Urgent Medical Device Recall (703.0KB) HS1.canada@philips.com Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). 22100 Bothell Everett Highway, Bothell . Stay up to date with the latest articles and news from the AED Blog. 5. 800-263-3342 Ext. If gel has almost completely separated from the pad, replace with spares if available and continue.
Technical Support: 1-800-442-1142, opt 5, opt 1. You're all done! On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. For Additional Information Contact. Do you currently own a Philips HeartStart OnSite or HeartStart Home AED? Product Support/Notices. Please answer question 6 before continuing. It does not always mean you must stop using the AED or return it. Q: Are the AEDs under this recall safe to use? Learn more. Reason. Any pad currently installed in or stored with an HS1/onsite/home aed could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Each state requires AED maintenance per manufacturer guidelines. Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable), Instructions for Downloading Viewers and Players, Class 2 Device Recall Philips, HeartStart HS1 Home Defibrillator, Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A, Affected serial numbers for Model # 5068A: A10A-01936, No matter the state of the pads, follow the voice prompts - AED devices talk users through the necessary actions. The recall will end when the FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy and desired end results. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Enter your email address to register for our newsletter subscription delivered on a regular basis! Class 2 Device Recall Philips, HeartStart HS1 Home Defibrillator. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. A: Yes. Philips is offering trade-in rebates depending on the age and model of the affected AED. Get low prices and fast, free shipping on all AEDs products. 5): M-F 9am - 6pm EST, *FREE Ship $99+ Contiguous US, Online Orders Only. These are automated external defibrillators (AEDs) used in cases of life-threatening irregular heartbeat (also known as cardiac arrhythmia or cardiac dysrhythmia) that leads to cardiac arrest. We pay our respects to them and their cultures, and to all Elders both past and present. During the peeling process, the gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Philips has received 115 complaints since 2010 (of which 84 complaints were received in 2021). 5. 1. Some AEDs save time by requiring inspections less frequently. If this occurs, the HS1 AED could deliver less effective or ineffective therapy. It will provide the outline of how to proceed and will address the depth of the recall, public warning and effectiveness checks. URGENT - Medical Device Recall Product:Date:Subject: Philips M5072A Infant/Child SMART Pads Cartridge August 20, 2021 Information regarding graphic on cover for pads cartridge incorrectly showing application to an adult instead of a child. 2. These updates are critical for the health and life of your AED. Email: info@actionfirstaid.ca This contamination could prevent an adequate connection between the pads cartridge and the AED. The serial number for the HeartStart FRx starts with the letter B, followed by 8 numbers and letters. Thanks for your comment. A: Yes. In this case, if your specific AED was part of the recalled defibrillators, you would need to call the company directly and they would provide you with future directions on how to mitigate the problem. HS1/onsite/home AED pads (pn: m5071a, m5072a) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take An AED manufacturer will recall a device in one of three scenarios: Depending on what action must take place, a recall will be either a correction or a removal. In the United States, contact Philips directly at 1-800-263-3342. Approx. Great for travel and small spaces. The system won't announce the next step until you are ready. Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Replacement options are being offered as a courtesy. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. Please check the . Philips: regulatory.canada@philips.com or 1-800-567-1080 FAQ Reference: Gel Separation, M5071A and M5072A, HS22005R/FSN-2021-CC-EC-012 Philips FR2 AED Pads Pediatric $110.00 USD. Subscribe to the occasional exclusive offers. Q: Are the AEDs under this recall safe to use? Philips AED Recall Continues By Linda G. Green The voluntary recall of HeartStart AEDs made between 2005 and 2012 by Philips Healthcare was issued late last year and is ongoing. What you need to know To replace your pads, locate the latch at the top edge of the AED and slide it to the side. Great for untrained responders or those with limited training. For Additional Information Contact. Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies . Instructions for Downloading Viewers and Players. If you do not have your unique customer code, please contact your local Philips Representative or call800-263-3342 and exit this survey. Philips will exchange affected devices with a replacement Philips AED free of charge. Strategic Partnerships and Healthcare Solutions, A: Yes. This website is using a security service to protect itself from online attacks. Store a spare SMART Pads cartridge with your HS1/OnSite/Home AED. (You can unsubscribe anytime), Copyright 2023 Courtemanche & Associates, Patricia Cook, BS, R.Ph, HACP-CMS, Head of Consulting. This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland. Please answer question 1 before continuing. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. Please answer question 7 before continuing. Adverse reactions or quality problems experienced with the use of this product Visit www.philips.com/aedaudiblechirps to hear an example. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. We value your privacy and will not share, sell or rent your personal information. Philips will provide redesigned replacement SMART Pads to all end users when these are available. The store will not work correctly in the case when cookies are disabled. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Please advise, thanks. Product defect correction - gel separation from the foam/tin backing when peeled from the yellow plastic liner, TGA Incident Reporting and Investigation Scheme (IRIS). Great for large or multi-location deployments. 1. Easy as 1-2-3 We've equipped OnSite with integrated SMART Pads that will provide feedback to the AED so it can adapt its voice instructions to your actions and your pace. In the United States, contact Philips directly at 1-800-263-3342. A Philips representative will reach out to you to help you identify any affected AED. Completing this form confirms receipts of the Urgent Medical Device Correction notice, understanding of the issue and required actions to be taken. ). 4. Q: Are the AEDs under this recall safe to use? After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided. Technical Support: 1-866-478-7463. Has Your Philips AED Been Recalled? A09J-01944, Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Affected AEDs are not recommended to be removed from service. Please answer question 9 before continuing. The device complies with the requirements of the Medical Device Directive, 93/42/EEC, and carries the CE-marking accordingly. Device Correction/Recall Look Up Tool. Philips has stated that they will begin a replacement program in late 2022. There are various outcomes to a recall. This notification updates the replacement instructions provided in the original notification dated 28- You are about to visit a Philips global content page. Philips Customer Services. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517. If your product has been recalled you will receive a letter via telegram, mailgram or first class letters unmistakably marked on the letter and the envelope. Instructions: Please complete no later than 30 days from receipt. Amy. If your device is still under warranty, you are entitled to receive a refurbished exchange unit at no cost, in accordance with our standard warranty terms. Your serial number can be found on the back of your device next to the battery well. either online, by regular mail or by fax. A10H-04433, When an emergency calls, respond with confidence. * The expiration date for M5072A Infant/Child Pads is 30 months from the date of manufacture. The pads cartridge will be released. Although the FDA can require a company to recall a device, recalls are usually voluntary. Please answer question 3 before continuing. Philips AEDs Philips HeartStart OnSite AED Part #: M5066A-CC Buy now and receive a FREE Carry Case! On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . A Philips representative will reach out to you to help you identify any affected AED. Please make sure to SUBMIT SURVEY on page 4. Courses run daily. The devices may continue to be used. Q: Do I need to replace my AED? All rights reserved. PHILIPS M5071A(adult)andM5072A(infant/child)padsforusewithHS1/OnSite/HomeAEDsmayexperiencegel 21-FEB-2022URGENTFieldSafetyNoticeseparationandreductionofgelsurfacearea Thisdocumentcontainsimportantinformationforthecontinuedsafeandproperuseof yourequipment Pleasereviewthefollowinginformationwithallmembersofyourstaffwhoneedtobeawareof