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.To address the display malfunction, the stm replaced the top display lcd assembly and related labels.The stm also installed the missing compressor temperature probe and was able to verify that the compressor output test did show a compressor temperature.The vacuum regulator was reading -310mmhg, upon initial testing.Despite being calibrated to -295mmhg, the the vacuum regulator drifted back to -310+ mmhg.The stm replaced the vacuum regulator.The vacuum regulator successfully calibrated and remained permanent.The stm identified various instances of fault code 58 and readings below ambient temperature but did not observe anything faulty or potential faulty.The stm then completed the pm and peformed all functional and safety tests per factory specifications and the iabp was returned to customer and cleared for clinical use.The full name of the initial reporter listed is (b)(6) who is a getinge employee whose contact details differ from that of the event site.Please refer to the following email as contact information for the initial reporter: (b)(6).
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