The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the 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 iabp.The stm spoke with the end user, and was told that there were multiple people around the iabp and it was not clear if someone may have accidentally changed the settings on the iabp.The stm inspected the iabp and was unable to duplicate the reported issue, the stm was also unable to verify the reported failures on the iabp's error logs as there was no indication of any related alarm at the time of the reported event.The stm returned at a later date to replace the safety disk per usage schedule and completed check out of the iabp.All functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.Full event site name: (b)(6).
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