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 01/27/2022 |
Event Type
malfunction
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Event Description
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A third-party service agent contacted stryker to report that their customer's 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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Third party service agent evaluated the customer's device and verified the reported issue.Stryker 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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Manufacturer Narrative
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After the therapy pcb assembly was replaced, a proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Stryker further evaluated the replaced part at the product assessment center (pac) and the cause of the reported issue was determined to be due to the shorted h-bridge diode package, designator cr30, on the therapy pcb assembly.
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Event Description
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A third-party service agent contacted stryker to report that their customer's 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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Search Alerts/Recalls
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