Model Number CR2 |
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 01/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker has requested the return of the device for evaluation.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 did not detect patient through defibrillation electrodes.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 duplicate the reported issue.There were not faults found with the device.The root cause was unable to be determined.Stryker archived the device and the customer was sent a replacement device.
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Event Description
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The customer contacted stryker to report that their device did not detect patient through defibrillation electrodes.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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Search Alerts/Recalls
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