The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as 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 confirmed the iabp unit had no ecg signal when using the customer's ecg cables during the evaluation.The stm performed a full performance check with known working ecg cables, and all tests passed and the stm did not find any issues with the iabp unit.The stm disposed of the non working ecg cabled and ordered a spare set of ecg cables.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was released to the customer and cleared for clinical use.The first name of the initial reporter has been abbreviated due to field character limit; the full name should read (b)(6).The full name of the event site was shortened due to field character limit; the full name is (b)(6).
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