The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed 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 evaluated the iabp unit and did not observe any error codes in the iabp log files, and was not ale to reproduce any faults.The stm was unsure of the customer's patient preparation or the condition of the connector pads that were used.Subsequently, 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.(b)(6).
|