The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) evaluated the unit and determined there was a vacuum leak in the drive manifold.To resolve the issue, the stm replaced the drive manifold.Unrelated to the reported issue, the stm found concealment labels to be missing and installed new concealment labels.The iabp passed all functional, and safety checks to factory specifications.The unit was returned to the customer and cleared for clinical use.
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