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.A getinge service territory manager (stm) was dispatched to evaluate the intra-aortic balloon pump (iabp).The stm checked the power supply intake, it was clean of debris and the fan was moving freely.The stm removed the power supply, removed the cover and vacuumed the interior then reinstalled the power supply.The stm 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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