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.A getinge service territory manager (stm) reported that the customer further explained that the hemodynamic numbers were incorrect and the waveforms somewhat chaotic.The stm ran the iabp and could not verify this.He tested the iabp and found the 30 psi to be slightly out of calibration.The stm calibrated the iabp and completed checks of the remaining calibrations finding all to be within tolerance.He then completed diagnostic and performance tests with no issues.The stm did notice that the battery in bay 1 did not seem to completely charge.The stm let the iabp fully charge and then completed preventive maintenance.The iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
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