![]() The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year. The watchdog agency in November announced its External Defibrillator Improvement Initiative aimed at improving the safety and efficacy of automated external defibrillators. ![]() Model DDU-C2300EN, unit needs new battery and looks to have never been used with. In June 2010, the AED manufacturer initiated a voluntary recall of 5,418 DBP-2800 battery packs for the Lifeline AED and ReviveR AED products.ĪEDs have fallen under more FDA scrutiny recently. Up for your consideration is this Defibtech Lifeline AED Reviver with View. This is the second recall in the last 12 months affecting the same products. For patients under 8 years old, or weighing. ![]() The company said its customers should keep their AEDs in service while the company sends out instructions on how to perform a corrective software upgrade. Lifeline/ReviveR DDU-100 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-100). Only 1 left Defibtech Adult Electrode Pads - DDP-2001 Training Only (1) 1. Defibtech also warned that conditions that cause the defect are not detectable by the AED’s periodic self test. Though failures are rare, the affected AEDs may cancel a life-saving shock during the device’s charging process, the company said. The Guilford, Conn.-based company said the recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. The FDA classified the recall as Class I because it believes the products’ possible malfunction could cause serious injury or death. The recall notice, which affects 65,885 AEDs distributed in the United States, applies to AEDs marketed under the Lifeline AED and ReviveR AED brands, the company said today. You can download a raw copy of the database here.Defibtech LLC initiated a global recall for two of its semi-automatic external defibrillators. OEM: Defibtech Material: Reviver View Common name: AED Weight: 2 Location: College Park, GA 30349 Serial Number: 400045231 SKU: Inv-8000217056Functional. The Defibtech Lifeline VIEW is easy to use, allowing both the trained and untrained user to perform a rescue using the device. Always cite the International Consortium of Investigative Journalists when using this data. AED Packages (2) AED Rentals (1) AED Units (15) Bleeding Control Kits (1) Cardiac Science (12) Defibtech (10) First Aid Kits (5) HeartSine (5). It is so simple and unintimidating to use that even non-medical personnel can effectively save lives. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. The AED that started it all The original Defibtech AED includes all mission critical features necessary to provide the most advanced treatment for Sudden Cardiac Arrest. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. The same device may have different names in different countries. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Medical devices help to diagnose, prevent and treat many injuries and diseases. The Limited Warranty shipped with Defibtech AED products serves as the sole and. Lifeline/ReviveR VIEW DDU-2300 and Lifeline/ReviveR ECG DDU-2450 AEDs may be used with Defibtech adult defibrillation pads (model number DDP-2001). Defibtech sent users a special data card which upgraded the software when inserted into the AED. According to a company press release, a problem was discovered with the self-test software that could cause a low battery condition to go unnoticed. So Defibtech created an eye-catching AED (Automatic External Defibrillator) that can be located instantly. In 2007, Defibtech initiated a voluntary recall of their Lifeline and ReviveR AEDs. Mere seconds can mean the difference between life and death. Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO. The Lifeline/ReviveR is referred to as the DDU-100 from this point. Defibtech makes great AED machines at very attractive prices. Defibtech's breakthrough in design technology makes it possible for every budget to afford a life-saving AED. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. Security and exchange commission filings for Defibtech Llc.
0 Comments
Leave a Reply. |