The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operating procedure since the serial number for the unit was not provided.No getinge service was requested from the customer or dispatched to the site.In an attempt to contact the customer, the customer reported that the iabp was not malfunctioning but the mounting plate.The customer contacted getinge for a replacement part, but only the mounting plate was available to purchase.However, the customer refused to purchase the mounting plate since it was too expensive.To the customer's knowledge, there is no damage to the iabp unit and is cleared for clinical use.Not returned to manufacturer.
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It was reported that the transport mount latch & screw knob assembly that secures the cardiosave intra-aortic balloon pump (iabp) to the transport module mount was broken.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
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