FDA labels Physio-Control ’s Lifepak 1000 recall as Class I

The FDA today labeled a select recall of Physio-Control Lifepak 1000 defibrillators over electrical issues as Class I.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The company’s Lifepak 1000 defibrillator is designed to deliver lifesaving electrical shocks to individuals with sudden cardiac arrest.
The device is being recalled due to an electrical issue which may cause it to shut down unexpectedly during treatment, due to wear and oxidation formation between the battery and device’s electrical contacts.
The recall affects 50,046 Lifepak 1000 defibrillator units in the US with product numbers 320371500XX. A total of 133,330 serial numbers are affected, manufactured and distributed between June 30, 2006 and Dec. 20, 2016, according to an FDA recall notice.
In January, Physio-Control launched a voluntary field action for the devices after receiving 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an intermittent connection between the battery and device electrical contacts. Physio-Control said it knows of 8 adverse events related to the issue.
Customers with non-rechargeable batteries who do not regularly remove them for inspection are more susceptible to this malfunction, although the company told its customers that the issue could affect any LifePak ...

Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Physio-Control Inc. Source Type: news