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 investigate.The stm initially evaluated the iabp unit and could not reproduce the customer's reported issue.Subsequently, the stm spoke to the facility's biomedical engineer who advised him that the issue is an intermittent one and requested that the stm look at the unit again.The stm returned to the event site, and again, evaluated the unit, but the issue was still not duplicated.The stm determined that the touchscreen operated correctly and then completed all diagnostic, 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.The full name is (b)(6) hospital.
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