A maquet (b)(4) fse (field service engineer) visited the hospital and evaluated the device.He found the fallen cover had no damage but the three nylon screws used to secure the cover to the device had broken.The fse in charge of the initial installation verified that all covers and screws were examined prior to the release of the operating room to the customer; everything was in place and there were no issues at that time.A review of the design of the cover was made, and mechanical evaluation testing was performed.No issues were found.During the investigation maquet observed a c-arm and other medical devices in close proximity to ceiling pendant, maquet believes the rot issue to be a failure of the operating room staff to be aware of their surrounding when positioning the other devices, and suspects one of these devices collided with the pendant, breaking the fastening screws.The fse replaced the screws to secure the cover during the visit and maquet has advised the customer to avoid collisions to ensure safe operation.Maquet medical systems usa submits this report on behalf of the device manufacturing facility.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.
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