Model Number 15 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2024 |
Event Type
malfunction
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Event Description
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The customer contacted stryker to report that their device did not deliver energy.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to 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.
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Manufacturer Narrative
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Stryker evaluated the customer's device and was unable to duplicate the reported issue.The root cause was unable to be determined.The device passed functional and performance testing and was returned to the customer.
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Event Description
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The customer contacted stryker to report that their device did not deliver energy.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Search Alerts/Recalls
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