Physio-Control—LIFEPAK 1000 Automatic External Defibrillators: May Unexpectedly Shut down during Treatment
January 25, 2017 | Risk Management News
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In a January 2017 Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Physio-Control states that it has received 34 reports of incidents in which customers have attempted to use the above defibrillators and the device shut down unexpectedly during patient treatment. This unexpected shut down is caused by an intermittent connection between the battery and device contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. Physio-Control also states that it is aware of 8 adverse events related to this problem. The firm has determined that the intermittent connection is a result of wear and subsequent oxidation formation between the battery and the device's electrical contacts. This has been observed in devices that are exposed to vibration and have a battery installed for an extended time without being removed from the device for inspection and then reinstalled. The manufacturer has not confirmed the...