This event has been recorded by zimmer biomet under (b)(4).Reported event: on 26 november 2019, it was reported from (b)(6) medical center that an evac unit¿s coupler wires were exposed.Dhr and repair history review: the previous repair report for intellicart 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 report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: on 26 november 2019, it was reported from (b)(6) medical center that an evac unit¿s coupler wires were exposed.On 26 november 2019, (b)(6) construction was contacted about the evac and dispatched a service technician to be at the site.The technician arrived at the site and confirmed the issue.He found that the boot between the coupler and the hoses had become unseated, allowing the hoses and cables to be exposed.He reseated the boot.During testing he found one of the connectors on the main control board was unplugged, so he plugged it back in and then verified proper functions before returning the evac to service.Per crm, a repair checklist was not required.Probable cause/root cause: the root cause of the unit¿s coupler having exposed wires was due to the coupler boot becoming unseated.The boot is a sleeve that covers the bottom of the coupler handle to the hose that leads the coupler to the main body of the evac.The boot coming partially off would result in the wires that lead the hoses to the handle being exposed to the open.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.
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