Model Number 20E |
Device Problems
Failure to Sense (1559); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.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 unexpectedly turned off and was not detecting patient rythmn via their defibrillation electrodes during a patient event.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Event Description
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The customer contacted stryker to report that their device unexpectedly turned off and was not detecting patient rhythm via their defibrillation electrodes during a patient event.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.
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Search Alerts/Recalls
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