It was reported to midmark that an x-ray unit (jb-70 intraoral dental x-ray system, serial (b)(4)) separated from its wall mount in a user facility.No injuries were reported.Root cause was determined to be installation error due to the mounting bolt not properly engaging with the wall stud.The bolt had been inserted at an angle that made it exit out the side of the wall stud.This mdr is being submitted as part of retrospective complaint at midmark corporation ((b)(6) midmark (formerly progeny) began filing mdrs for x-ray units separating from their wall mounts in (b)(6) 2009 (refer to mdr 1423380-2009-00006).All subsequent incidents involving units fully separating from the wall mount have been submitted to cdrh as mdrs.However, as part of retrospective complaint review, midmark has identified this unreported incident that occurred prior to (b)(6) 2009 and has decided to report this incident for consistency.
|