Updated field: b4, d9, e1-(site country, site email), g3, g6, h2, h3, h4, h6(medical device ¿ problem code, type of investigation, investigation findings, investigation conclusions),h10.It was reported that the cs300 intra-aortic balloon pump (iabp) unit had error code 4561.Customer complained that during patient transport the unit shut down.No patient death or injury reported.A getinge field service engineer (fse) evaluated the unit and found the k3/k5 assy was loose and touched the solenoid driver board causing it to short.There was no damage to any parts.Fse secured the assy and also performed a pm during this call.Unit passed all functional and safety tests per factory specifications.Returned unit to the customer and cleared for clinical use.
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