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.The stm that found the issue replaced the patient interface module (pim) and performed full calibration, functional and safety tests.The iabp was then returned to customer and cleared for clinical use.The initial reporter named is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).
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