DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Display or Visual Feedback Problem (1184); Power Problem (3010); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/16/2019 |
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) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported "high temperature" issue.However, the fse replaced the scroll compressor as a precautionary measure.The iabp was able to pass all the leak tests, and the fse performed all functional and safety checks to meet and pass factory specifications.The iabp was then released to the customer and cleared for clinical service.
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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 power supply issue.The unit was heating up and displayed a high temperature alarm.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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