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) was dispatched to evaluate the iabp unit.Upon initial inspection, the stm found electrical test failure code #53 along with autofill failures.The shuttle transducer was out of calibration.Upon inspection of the shuttle transducer, it was noted there was too much vacuum grease on o-ring and inside the transducer, clogging the port.The transducer was cleaned and recalibrated.The iabp passed all testing and was cleared for clinical use.The customer has been performing maintenance on their own without any certified technicians.The stm recommend they send a technician to training or call the stm for proper pms in the future.The full name of the event site (b)(4).
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