It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) had multiple plastic panels with physical damage.The top lcd cover was cracked, the upper inside lcd bezel was cracked, and the fiber optic door assembly was broken.There was no patient involvement reported.
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Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10 the stm that encountered the issue replaced the cap screw, upper display hinge cover & upper panel and completed a full pm.All tests passed to factory specifications.Returned to the customer and released for clinical use.
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