Model Number 15 |
Device Problems
Loss of Power (1475); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
Event Type
malfunction
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Event Description
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The customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported 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.There was no patient involvement reported with the event.
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Event Description
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The customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Stryker evaluated the customer's device and verified the reported issue.Stryker determined that the cause of the reported issue was due to a failed system pcb assembly.A replacement for this part is no longer available due to part obsolescence.The device was returned to the customer unrepaired.
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Search Alerts/Recalls
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