Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to duplicated the reported issue using a test catheter and trainer.The fse inspected the pneumatic module assembly (pim) and found saline residue inside pim channels and on safety disk.The fse replaced the pim.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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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: a1, b5, b6, b7, d9, g1(contact person), h6(component codes & impact codes).
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