(b)(4).The device history record (dhr) for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) that the unit would not power up when connected via wall or evac.On (b)(6) 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived and found there was no issue with connecting to the evac, but found the power inlet module melted.He proceeded to replace the power inlet module (part # 90204), then tested the unit to verify proper operation.The device was tested, inspected, and repaired.Service work order dms-50556-z1c2d8 on 18 mar 2019.The root cause of the reported event was due to a bad power inlet module.The power inlet module will supply power to the unit when it is connected to the power socket, if it is not functioning as intended it would not turn on the unit.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.(b)(4).Device evaluated by external contractor.
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