Model Number 0998-00-0800-53 |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device(10).A getinge field service engineer (fse) was dispatched to evaluate this unit.Fse inspected the unit and found errors 37 with arg 0x10 and error 16 with arg 0x6 with all pointing to no helium in unit or a kinked balloon.Fse tested the unit and could not duplicate the failure.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) would not autofill.It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) would not autofill.It is unknown under which circumstances this event occurred; however there was no adverse event was reported.
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Search Alerts/Recalls
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