Last week, Redmond, WA-based Physio-Control launched a voluntary field action for its LIFEPAK 1000 automated external defibrillator after it received 34 reports of the device unexpectedly shutting down during patient treatment.
According to the company, the issue is caused by an intermittent connection between the battery and the device's electrical contacts. As a result, the life-saving device may not work during a resuscitation attempt, which could harm the patient, or worse.
The company is already aware of eight adverse events related to this issue.
The intermittent connection is a result of wear and oxidation that forms between the battery and the electrical contacts. It happens over time in devices that are exposed to vibration and have a battery installed for long periods of time, which is problematic as it is designed for first responders.
The issue can affect any LIFEPAK 1000 device, but customers with non-rechargeable batteries who do not routinely remove the battery for inspection are more susceptible. It's worth noting that, in the instructions, the company tells users to routinely remove and inspect the batteries.
The company has advised customers to implement a weekly schedule of battery removal and re-installation, which will reduce the likelihood of this issue from occurring. They even offered and official Battery Removal and Re-installation Checklist.
Physio-Control is working on a hardware device correction and the company will contact customers once it is ready.
Last April, Physio-Control was acquired by Stryker for $1.28 billion.