This event has been recorded by zimmer biomet under (b)(4).Dhr review: the previous repair report for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Evaluation of device: on 5 november 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site and confirmed that the cart was giving level sensor range errors for both cylinders.The technician replaced the level sensors for each cylinder (part #91584 and lot # 0026756, 0025972) and found that the issue persisted.The technician then replaced the unit control board (part #91940 and lot #0040943) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Probable/root cause: the root cause for the reported event that the unit was issuing level sensor range errors was due to a defective control board.The control board designates the flow of electric current to the designated components, such as the level sensor.The level sensor measures the volume of fluid in the cylinder, and when defective can provide the incorrect or no output.A defective control board prevents the flow of current to the level sensor, and therefore prevents the unit from reporting the correct fluid levels.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board and level sensors were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended.Complaint trending procedure for any adverse trends that may warrant further action.
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