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 arrived on site to find the touch screen was functioning.The stm cleaned the edges of the touch screen and recalibrated.While performing the safety checks, the stm found the safety disk was due to be replaced due to the maximum number of assist cycles reached.The stm replaced the safety disk and ran the safety disk leak test.All calibration, functional and safety tests passed per factory specifications and the iabp was returned to the customer and cleared for clinical service.
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