The previous repair record for ultra evacuation unit 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 record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number 33527, the device was noted to have been previously repaired nine times, the previous repair being for an issue with the water valves.The water valves are not associated with the current repair.Thus, this repair was a non-related issue.On (b)(6) 2018, it was reported from sutter maternity and surgery center that a unit had some exposed wires on the coupler handle.Replite was contacted about the cart and dispatched a service technician to be at the site.On (b)(6) 2018, the technician confirmed that the unit had exposed wires and noted that the coupler boot was not secure.He secured the coupler boot on the unit per manufacturer¿s specifications and then verified that the device was functioning as intended.The unit was then returned to service without incident.There is no repair checklist required as per the crm.Service work order (b)(4) on (b)(6) 2018.Although the reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the coupler boot was secured, it cannot be determined from the information provided what caused the coupler boot to move and allow wires to be exposed.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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