DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/06/2019 |
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-conformance's related to the reported event were noted.A getinge fse was dispatched to evaluate the iabp unit and was able to duplicate the customer's reported issue.The fse replaced the pneumatic module assembly the completed all leak tests which were noted to pass.Subsequently, the fse 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 by the customer's perfusionist that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a "gas loss" alarm.The iabp unit was swapped out with another iabp unit and taken to the customer's perfusion pump room.The iabp unit was connected to a trainer and balloon and pumping was started, and it was observed that the iabp unit continued to alarm "gas loss" after a few minutes.The customer was advised to remove the iabp unit from service and wait for a getinge field service engineer (fse) to perform an evaluation.There was no report of patient harm, serious injury or adverse event.
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