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 evaluate the iabp.The stm was able to verify the reported issue; to address the issue the stm replaced the faulty fiber optic assembly.A full pm was performed and the stm verified that the iabp was working normally for end user.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.(b)(6).
|