Model Number 15 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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The customer contacted stryker to report that their device would unexpectedly reset.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
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Manufacturer Narrative
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A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A cause of the reported issue could not be determined.
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Event Description
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The customer contacted stryker to report that their device would unexpectedly reset.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
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Search Alerts/Recalls
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