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.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm performed functional tests and was unable to find any issue.The vacuum levels were within specification.He ran the iabp for 20-30 minutes at 130 bpm without any issues but two low vacuum alarms registered in the alarm log files and printed on the printer.The stm rebuilt the compressor motor using a 5000 hour kit.The test was repeated without any further issues.The stm noted that the safety disk was about to expire so replaced it.The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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