Model Number N/A |
Device Problems
No Display/Image (1183); Loss of Power (1475); 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.
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Event Description
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It was reported that while the cardiosave intra-aortic balloon pump (iabp) was used on a patient and upon transferring of the patient, the iabp stopped pumping and the monitor went black, then the iabp alarmed and shutdown.An attempt was made to power on the iabp by turning it off and on.The iabp then restarted pumping normally.No patient harm or adverse event was reported.
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Manufacturer Narrative
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The getinge field service engineer (fse) evaluated the iabp and was unable to duplicate the reported malfunction.However, as a precaution the fse replaced the cable, to backplane cable cord and the coiled cable.The fse the performed all functional and safety checks to meet factory specifications.The iabp passed all functional and safety test per 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 while the cardiosave intra-aortic balloon pump (iabp) was used on a patient and upon transferring of the patient, the iabp stopped pumping and the monitor went black, then the iabp alarmed and shutdown.An attempt was made to power on the iabp by turning it off and on.The iabp then restarted pumping normally.No patient harm or adverse event was reported.
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Search Alerts/Recalls
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