PREVA
Received Apr 29, 2015 · Event occurred Mar 31, 2015
Report 1423380-2015-00014 · MDR key 4742626
Device
Product problems
- Material Separation
- Improper or Incorrect Procedure or Method
- Installation-Related Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2015 IT WAS REPORTED TO MIDMARK BY A DEALER TECH THAT AN X-RAY UNIT (PREVA INTRAORAL DENTAL X-RAY SYSTEM, SERIAL NO (B)(4)) SEPARATED FROM ITS WALL MOUNTING AT A USER FACILITY IN (B)(4). NO INJURIES WERE REPORTED. THE DEALER TECH VISUALLY INSPECTED THE WALL AND PROVIDED PHOTOGRAPHS TO MIDMARK. ROOT CAUSE COULD NOT BE CONFIRMED; HOWEVER, THE INFO COLLECTED MAY SUGGEST THAT THE UNIT SEPARATED FROM THE WALL DUE TO IMPROPER INSTALLATION. THE PHOTOGRAPHS REVIEWED DO NOT INDICATE THAT THE MIDMARK INSTALLATION GUIDE TOOL WAS USED. THIS TOOL IS USED TO LOCATE THE CTR OF THE STUD TO HELP ENSURE STABLE MOUNTING. THE ELECTRICAL BOX WAS ALSO PLACED BEHIND THE CHASSIS, WHICH IS NOT A CONFIGURATION RECOMMENDED BY THE INSTALLATION INSTRUCTIONS.