Model Number 15 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control 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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A customer contacted physio-control to report that their device had powered off multiple times during use.There were no reports of patient use associated with the reported event.
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Event Description
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A customer contacted physio-control to report that their device had powered off multiple times during use.There were no reports of patient use associated with the reported 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.After replacing the system pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The removed part was further evaluated by stryker product analysis center(pac) and the reported issue was verified.The cause of the reported issue was determined to be due to an inoperable crystal, y1, on the single board computer on the system pcb assembly.
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Search Alerts/Recalls
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