DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Restricted Flow rate (1248)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 as per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) was dispatched to evaluate the iabp and upon arrival, reseated pim.The stm then began by checking for pneumatic leaks, but found none.Subsequently, the stm verified proper function of compressor, adjusted pressure regulator to full open state and back to within specification.During failure diagnosis, the stm noted error codes consistent with a possible need to replace executive processor pcb.The stm replaced executive processor pcb.Finally, a full functional check and safety test was performed.The iabp was returned to customer and cleared for clinical service.
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Event Description
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It was reported by the customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed restriction alarm.The device was removed from patient and replaced with another device.The patient therapy then continued.There was no harm or injury to the patient and no adverse event was reported.
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Event Description
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It was reported by the customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed restriction alarm.The device was removed from patient and replaced with another device.The patient therapy then continued.There was no harm or injury to the patient and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.
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