Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment.
The Redmond, Washington-based company has received 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.
The intermittent connection results from wear and subsequent oxidation formation between the battery and device electrical contacts, the company said. The condition can happen in devices that are exposed to vibration and have a battery installed for long periods of time.
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 1000 device.
Physio-Control said it is contacting customers and advising them to remove and reinstall the battery from their devices as soon as possible. The company is also recommending that its customers reinstall batteries in the LifePak defibrillator on a weekly basis. Removing and reinstalling batteries will clean the contacts of oxidation and reduce the likelihood of the device suddenly shutting down.
The company will initiate a hardware device correction for all affected devices and said it will contact customers to schedule device corrections once the correction is ready for implementation.