The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Recently, the FDA warned that about 300,000 defibrillators manufactured by Cardiac Science Corporation have potential malfunctions. According to the FDA, these malfunctions don’t show up on device self-tests, but may prevent delivery of life-saving shocks.

The devices affected by the warning include some Powerheart and CardioVive models of AEDs, manufactured between August 2003 and August 2009. Some of the potential problems include failure to recognize pad placement during use, interference from background noise, and interrupted electrocardiography analysis. Though the FDA is not issuing a recall of these devices, it is urging users to take certain precaution if they are currently using affected AEDs. Some of those recommendations include using an alternate AED if available, until the malfunctioning model has been replaced or repaired, for at-home use, only use the device when necessary, in clinical settings, use a manual defibrillator if available.

Comments are closed.

Of Interest