PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
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Model Number 20 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/24/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control replaced both the system controller (sc) and user interface (ui) pcb assemblies and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further examined the removed sc pcb assembly and determined that the cause of the reported issue was a broken filter, designator fl3.This led to the device locking up during the boot-up cycle and would prevent therapy from being delivered, if necessary.It was also observed that the negative terminal of the coin-cell battery socket, designator b1, was broken; however that did not contribute to the lockup condition.The ui pcb assembly was an ancillary part and there was no failure of this assembly.
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Event Description
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The customer contacted physio-control to report that their device appeared to be stuck on the self-test in progress screen and, as a result, would not complete the boot-up cycle.In this condition defibrillation therapy would not be possible.There was no patient use associated with the reported event.
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Manufacturer Narrative
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(b)(4): physio-control examined the customer's device and verified the reported issue.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Search Alerts/Recalls
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