Physio-Control has announced a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances in which the device has shut down unexpectedly during patient treatment, according to a statement released by the FDA.
The company reported 34 cases in which customers have attempted to use the LIFEPAK 1000 defibrillator though the device shut down due to an intermittent connection between the battery and the device electrical contacts. In this situation, the defibrillator may not be able to deliver therapy during a resuscitation attempt, which may expose patients to serious harm or death.
The intermittent connection between the battery and device electrical contacts is a result of wear and subsequent oxidation formation. The condition can occur over time between LIFEPAK 1000 devices that are exposed to vibration and have a battery installed for long periods of time. Customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the LIFEPAK 1000 Defibrillator Operating Instructions, are more susceptible to this issue.
The company advises customers to immediately remove and reinstall the battery from the device. Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for LIFEPAK 1000 devices. Removing and reinstalling the battery will clean the contacts of oxidation and reduce the likelihood of the issue from reoccurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices. The company will contact customers to schedule device corrections once the hardware correction is ready for implementation.
- Physio-Control Launches Voluntary Field Action for LIFEPAK 1000 Defibrillator [press release]: The US Food & Drug Administration; Published January 13, 2017.