Manufacturer's investigation conclusion: the reported event of discoloration to the patient cable and handle of the mobile power unit was confirmed.The mobile power unit (mpu) (serial number: (b)(6) ) was returned to the service depot and evaluated and tested on 24feb2021.Upon initial observation, it was found that the patient cable and handle of the mpu were discolored.The product was tested and was found to pass all testing without issue.A root cause for the discoloration was unable to be conclusively determined through this analysis.The heartmate 3 instructions for use (ifu) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Additionally, heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories for damage, and to replace any equipment that appears damaged or worn.The heartmate 3 patient handbook and heartmate 3 ifu caution users 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.The device history records were reviewed and the records revealed the mobile power unit (serial number: (b)(6) ) was manufactured in accordance with manufacturing and qa specifications and was shipped to the customer on 19feb2018.No further information was provided.The manufacturer is closing the file on this event.
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