Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Service agent evaluated the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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A third party service agent contacted physio control to report that during the preventative maintenance of their customer's device they observed that the device would deliver monophasic shocks.In this state there will be a partial loss of defibrillator output energy due to a loss of a portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no report of patient use associated with the reported event.
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Event Description
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A third party service agent contacted physio control to report that during the preventative maintenance of their customer's device they observed that the device would deliver monophasic shocks.In this state there will be a partial loss of defibrillator output energy due to a loss of a portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no report of patient use associated with the reported event.
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Manufacturer Narrative
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After the therapy pcb assembly was replaced and other unrelated repairs, a proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.The replaced spare parts were further evaluated by stryker.The root cause of the reported issue was determined to be a diode, designator cr30, on the therapy pcb assembly.
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Search Alerts/Recalls
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