The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.(b)(6).The stm noted fan issue during a previously scheduled service call.The stm replaced the cooling fan then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
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It was reported that, during a service call for a different issue, the getinge service territory manager (stm) noted the "back" system cooling fan was not operational on the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, thus no adverse event was reported.
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