Model Number 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC |
Device Problem
No Audible Alarm (1019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2022 |
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) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter is (b)(6).
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Event Description
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It was reported by the customer during power up the cardiosave intra-aortic balloon pump (iabp) unit displayed an alarm.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device|10: a getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter is (b)(6).
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Event Description
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It was reported by the customer during power up the cardiosave intra-aortic balloon pump (iabp) unit displayed an alarm.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.However, the fse verified alarm codes 111, 112 and 118 in the logs and also verified all electrical connections and inspected and replaced the coiled cord to display as a precautionary measure.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during daily testing when powered on the cardiosave intra-aortic balloon pump (iabp) unit sounded an alarm.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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