Model Number CR2 |
Device Problems
Failure to Deliver Shock/Stimulation (1133); No Audible Prompt/Feedback (2282); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2024 |
Event Type
malfunction
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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 a non-critical issue with their device.During evaluation it was found that the device did not emit audio prompts, was unable to shock, and continuously rebooted.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 evaluated the customer's device and was unable to duplicate the reported issue but was able to verify the reported issue was logged in the device¿s memory.The root cause of the reported issues was unable to be determined.The device was archived by stryker and the customer received a replacement device.
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Event Description
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The customer contacted stryker to report a non-critical issue with their device.During evaluation it was found that the device did not emit audio prompts, was unable to shock, and continuously rebooted.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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Search Alerts/Recalls
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