DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2021 |
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, but was unable to reproduce the reported issue.After troubleshooting the unit, the fse determined that the iabp unit was not properly inserted into the chassis, and therefore, the batteries could not charge.The fse then 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 when additional information is provided.The full name of the initial reporter that is abbreviated is herr (b)(6).
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Event Description
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It was reported that after removing the cardiosave intra-aortic balloon pump (iabp) from a patient, the batteries would not charge.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, d11, 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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