JB-70
Received Feb 25, 2015 · Event occurred Jan 21, 2015
Report 1423380-2015-00010 · MDR key 4551489
Device
Generic name
Unit, X-ray, Extraoral With Timer
Manufacturer
Midmark CorpModel number
JB-70Catalog number
JT27098
Product problems
- Crack
- Installation-Related Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO MIDMARK THAT ON (B)(6) 2015, 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. INVESTIGATION OF THE MOUNTING SITE BY A DEALER TECHNICIAN DETERMINED THAT THE TOP LAG SCREW WAS NOT CENTERED IN THE STUD, AND THE STUD HAD CRACKED. ALSO, PHOTOGRAPHS SHOW THAT THERE IS CONTINUOUS WALLPAPER AT THE SITE OF MOUNTING, WHICH INDICATES THAT AT THE TIME OF INSTALLATION, THE WALL HAD NOT BEEN OPENED TO VISUALIZE THE STUD AND THAT THE "INSTALLATION GUIDE" TOOL HAD NOT BEEN USED. BECAUSE THE INSTALLATION INSTRUCTIONS REQUIRE THAT THE LAG SCREWS ARE CENTERED IN THE STUD AND THE STUD BE LOADED VISUALLY THROUGH OPENING THE WALL USING THE INSTALLATION GUIDE, ROOT CAUSE OF THE MOUNTING FAILURE IS DETERMINED TO BE IMPROPER INSTALLATION.