The FDA issued a safety alert Jan. 14 regarding Physio-Control's LIFEPAK 1000 defibrillator after reported incidents of the device shutting down suddenly during treatment.
Thus far, there have been 34 reported incidents and eight adverse events linked to this issue. Customers have noted the device shuts down due to an irregular connection between the battery and device electrical contacts.
According to Physio-Control, the patchy connection is due to wear and subsequent oxidation formation between the battery and device electrical contacts. This condition occurs over time and customers with non-rechargeable batteries who do not regularly remove the battery are more susceptible.
The LIFEPAK 1000 defibrillator is an automatic external defibrillator. These devices are used to treat sudden cardiac arrest, which can cause death in minutes, according to the National Heart, Lung, and Blood Institute.
The company is contacting customers and asking them to remove and reinstall the batteries in their device. Physio-Control will also issue a hardware device correction for all affected LIFEPAK 1000 devices.