Catalog Number 0998-00-0800-53 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2017 |
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 not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm reported that in order to fix the iabp he replaced the scroll compressor.The iabp then passed all functional and safety tests to factory specifications and was released back 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) generated a maintenance alarm and a compressor servicing issue was detected.The iabp was swapped out in order to continue therapy.The exact alarm generated was not reported.No patient injury or adverse event was reported.
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Search Alerts/Recalls
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