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
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and ran a performance test for half hour, but was unable to reproduce the reported issue.The fse also did not find overheating alarms in the logs.The fse performed functional and safety checks to meet factory specifications.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 full name of the initial reporter that is abbreviated is (b)(6).
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed an overheating alarm.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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