Catalog Number 0998-00-0800-53 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 per the company standard operating procedure since the device manufacture date is greater than one year from the event date.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) external ecg is not working.Further details were not reported.No patient involvement or adverse event was reported.
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Manufacturer Narrative
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A getinge service territory manager (stm) evaluated the iabp and found that the front end board was defective.The stm replaced the board and while installing the board a pin connector was damaged.The stm installed a second board successfully and was able to complete all diagnostic, performance and safety tests.The iabp was then approved from clinical use and returned to the customer.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) external ecg is not working.It was later reported that the event occurred during use on a patient.No patient harm or adverse event was reported.
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Search Alerts/Recalls
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