DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was giving an intermittent autofill failure while being operated.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: during the semi-annual maintenance the getinge field service engineer (fse) found that the unit was failing with an autofill failure alarm.He found the autofill failure was cause by safety disk.The safety disk was replaced less than a year ago, to fix the issue he replaced the safety disk and functional tested without any more autofill failures.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The initial reporter is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6), biomed.
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Search Alerts/Recalls
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