PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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Model Number 20 |
Device Problems
Overheating of Device (1437); Failure to Power Up (1476)
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Patient Problem
No Information (3190)
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Event Date 09/05/2014 |
Event Type
malfunction
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Event Description
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It was reported to physio-control that the customer had used their device to provide external pacing to a patient.After approximately 30 minutes, it was observed that there was smoke coming from the device and that the device was very hot.The device was then turned off, and a back-up device was used to continue treatment.It was also reported that the device was working until it had been switched off.Physio-control observed during device evaluation that the device would not power on with either ac or dc power.There was patient use associated with the reported event however, the patient outcome was not reported.
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Manufacturer Narrative
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Physio-control evaluated the device and verified the reported failure.It was observed that the power pcb showed burn marks.Physio-control then replaced the power module assembly.Proper device operation was observed through functional and performance testing.Following repair, the device was returned to the customer for use.
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Manufacturer Narrative
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Physio-control further evaluated the removed power module assembly (power supply assembly and power pcb assembly).Physio-control determined that the cause of the reported failure was due to a metal oxide varistor, designator mv3 on the power supply assembly that had shorted which caused the device not to have any 12 volt output and no battery charge.The power pcb assembly had smoke damage, but functioned properly.
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Search Alerts/Recalls
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