Model Number N/A |
Device Problems
Defective Device (2588); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/11/2018 |
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 reviewed and no non-conformances related to the reported event were noted.Additional information has been requested, and we will report accordingly when it becomes available.The full event site name is (b)(6) hospital.
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Event Description
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It was reported that after some tests were performed by a getinge field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) generated error code #50.It was detected that the motor control pcb was defective and needed to be replaced.There was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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A company representative has provided clarification on this complaint event and has been updated accordingly.In addition, the getinge fse later determined that the batteries of the iabp were completely discharged during the installation and that the motor controller board was not defective because the iabp worked fine when he attempted to replace the board.The fse tested the iabp for a further 24 hours without replacing the board and verified that it functioned appropriately and the error was not repeated.All calibration, functional and safety tests were performed, and the iabp passed per factory specifications.The iabp was released to the customer for clinical use.Since the motor controller board was not replaced, no failure analysis is necessary.
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Event Description
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It was reported that after some tests were performed during installation of the cs100 intra-aortic balloon pump (iabp) by a getinge field service engineer (fse), the iabp generated error code #50.It was detected that the motor control pcb was possibly defective and needed to be replaced.The clinical engineering technician and responsible physician at the facility was present when this issue occurred.There was no patient involvement, and no adverse event was reported.This is a possible out of box failure.
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Search Alerts/Recalls
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