DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-55 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to investigation.The fse evaluated the iabp unit and observed that the reported issue involved the power supply board.At this time, repairs are ongoing and a supplemental report will be submitted when additional information is provided.The full event site name in is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) was not working on mains power.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Manufacturer Narrative
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Updated data: b4,e1(email),e2,e3,g2,g3,g6,g7,h2,h10,h11.Corrected data: b5,d1,d5,d10,h6(impact).
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Event Description
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It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) was not working on mains power.There was no patient involvement.
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Manufacturer Narrative
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Updated fields: e1(site country), h6 (,type of investigation, investigation findings, component codes, investigation conclusions).E3 is unknown (initially it is submitted as "other healthcare professional").A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the power supply, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released for cleared for clinical service.
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