The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge field service engineer (fse) reported that the biomed tech from ny cornell observed depleted helium tank.The helium tank was replaced with a new helium tank, which corrected customer failure.The biomed declined service.There was no issue with the iabp; the failure was due to operator error.
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