DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Pumping Stopped (1503); Moisture or Humidity Problem (2986)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to investigate.The stm arrived at the customer's site and noted that no visible moisture was observed in the pneumatic module assembly (pim).As a precautionary measure, the stm performed the condensation removal procedure.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped pumping, and excessive condensation was observed in the catheter, and the iabp unit was swapped out.There was no patient harm and no adverse event was reported.
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Search Alerts/Recalls
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