Manufacturer's investigation conclusion: the reported events of the mpu¿s patient cable being discolored, and the mpu's handle having glue stuck to it, were both confirmed.The returned mpu (serial number (b)(6) was tested at the european distribution center.Upon arrival, the observed damaged components were replaced with new components.The mpu was functionally tested and was found to perform as intended.Preventive maintenance was performed, and the mpu was returned to the rental pool after passing all tests per procedure.The mpu¿s patient cable was then tested by the ppe department, and was found to perform as intended throughout all testing despite the observed discoloration, even when the cable was manipulated during testing.The root causes of the reported events were unable to be conclusively determined through this analysis.Incidental findings: superficial jacket damage on mpu cable.Review of the device history record for the mobile power unit, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook instructs users to regularly inspect their equipment for damage and to replace any components that appear damaged or worn, including their mpu and mpu cable.Heartmate 3 patient handbook cautions the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing this event.
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