DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number 0998-00-0800-53 |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The iabp passed all manifolds leak test.The stm inspected the pneumatic interface module (pim), and found condensation in the pim tubing.The stm also found two kinks in the tubing restricting the helium flow to the tidal volume disk.The pim was replaced.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) had a condensation alarm.No patient harm, serious injury, or adverse event was reported.
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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) had a condensation alarm.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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