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) evaluated this unit and was unable to reproduce the reported issue.The stm tested with mini-sim, trainer and fiber optic tester, all passed.The iabp passed all functional and safety tests per factory specifications and was returned to customer and cleared for clinical use.
|