DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Failure to Charge (1085); Failure to Power Up (1476)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer did not request for getinge to evaluate the iabp unit involved in this event, at this time.A getinge field service engineer (fse) conversed with the initial reporter and customer's biomedical staff member and confirmed that the reported issue was as a result of the iabp rescue unit not being completely engaged inside the cart.The issue was resolved when the customer pushed the unit all the way into the cart.The customer confirmed that the unit powered on and that the batteries began to charge.The iabp was then released to the customer for return to clinical service.(b)(6).Device not returned to manufacturer.
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Event Description
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It was reported that during a pre-use check, the cardiosave intra-aortic balloon pump (iabp) batteries were not charging and would not turn on.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a pre-use check, the cardiosave intra-aortic balloon pump (iabp) batteries were not charging and would not turn on.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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