Model Number 1000 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Event Description
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The customer contacted stryker to report that their device was not recognizing their defibrillation electrodes.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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Stryker 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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Event Description
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The customer contacted stryker to report that their device was not recognizing their defibrillation electrodes.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
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Search Alerts/Recalls
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