DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
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 03/31/2021 |
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.However, the fse found that the iabp unit console was not fully inserted into the cart, thereby causing the inability to charge the battery.After properly inserting the unit into the cart, 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.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) would not charge the battery.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, h2, h5, h6, h10.The device history record (dhr) for this iabp was reviewed and no non-conformances related to the reported event were noted.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) would not charge the battery.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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