Model Number 0998-00-0800-53 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10 /213) a getinge field service engineer evaluated the iabp and was unable to verify report of battery charging issue.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) failed leak test and there was also a battery charging issue.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.This submission is for the reported battery charging issue.A separate report will be submitted for the reported leak test failure.
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Manufacturer Narrative
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Mfg report number for leak test failure 2249723-2021-01400.
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Search Alerts/Recalls
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