Model Number 20E |
Device Problem
Loss of Power (1475)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control continues to investigate the reported issue 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 third-party service agent contacted physio control to report that their customer's device had unexpectedly lost power.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control evaluated the customer's device and was unable to verify and reproduce the reported issue.A proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Root cause is unable to be determined.
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Event Description
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The third-party service agent contacted physio control to report that their customer's device had unexpectedly lost power.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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