Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs) Recalled Because Software Defect May Cause Failure to Resuscitate Patient

The US FDA informs Emergency Medicine healthcare personnel and Risk Managers that Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs) are recalled because there is a potential of failure to resuscitate the patient due to software defect.

Background of Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

Lifeline and ReviveR Automated External Defibrillators (AEDs), by Defibtech LLC, are used in cases of sudden cardiac arrest when the patient is not breathing, unconscious and unresponsive.

FDA Alert on Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

FDA’s reason for the recall is that Lifeline and ReviveR AEDs with software version 2.004 or earlier, due to software defect, may cause the AED to cancel shock during the charging process and might fail to resuscitate the patient.

The affected model is DDU-100 series.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

“Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction.”

Contacting the FDA to report cases with Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

In case of detection of adverse events or side effects related to the use of Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.