Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and replaced the pneumatic module assembly (pim) then performed the associated pressure test.The iabp unit ran without issue for twenty (20) minutes.Subsequently, the fse 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.A supplemental report will be submitted upon completion of our investigation.
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