Manufacturer's investigation conclusion: the reported event, of the black power cable lead connector mpu being damaged, was confirmed when the unit was evaluated by technical service.The threads on the black power cable lead connector were damaged and marred.Functionally, the damaged threads did not affect threading and locking the mating controller connector onto the mpu.The white power lead connector on the mpu was not damaged.The mpu was repaired by replacing the patient cable assembly.The repaired unit was functionally tested and returned to the customer.The cause of the thread damage was unable to be determined through this analysis.The mpu assembly was made in jul 2019.The unit was packaged and placed into stock on jul 27, 2019.The unit was sent to the customer on sep 5, 2019.The unit had no previous services.Set up and use of the mobile power unit (mpu) are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas instructions for use (ifu).Specific warnings and cautions regarding the mpu's set up, the potential tripping hazards presented by the mpu patient cable and power cord, and the electrical outlet used (including location and accessibility) are given in both the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.The heartmate 3 lvas patient handbook states that the patient should contact their hospital should they believe their equipment has issues - "if for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.".No further information was provided.The manufacturer is closing the file on this event.
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