PREVA
Received Apr 22, 2015 · Event occurred Mar 23, 2015
Report 1423380-2015-00012 · MDR key 4723475
Device
Generic name
Unit, X-ray, Extraoral With Timer
Manufacturer
Midmark CorpModel number
PREVACatalog number
P7017
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2015, IT WAS REPORTED TO (B)(6) TECHNICIAN THAT AN X-RAY UNIT (PREVA INTRAORAL DENTAL X-RAY SYSTEM, SERIAL NO. (B)(4)) BEGAN TO SEPARATE FROM ITS WALL MOUNTING AT A USER FACILITY IN (B)(6). WHILE AT THE FACILITY, THE TECHNICIAN TIGHTENED THE SCREWS TO BETTER SECURE THE UNIT TO THE WALL AND REPORTED TO (B)(6) THAT HE PLANS TO RELOCATE THE MACHINE AT A FUTURE DATE. (B)(6) WILL BE SENDING A LETTER TO THE DEALER ORGANIZATION TO REMIND THEM THAT THE MACHINE REQUIRES RELOCATION TO PREVENT FUTURE SEPARATION FROM THE WALL. NO INJURIES WERE REPORTED. AT (B)(6) REQUEST, THE TECHNICIAN AGREED TO RETURN TO THE USER FACILITY TO PERFORM AN ON-SITE INSPECTION OF THE MOUNTING TO DETERMINE THE CAUSE OF SEPARATION. (B)(6) IS CURRENTLY WAITING ON THE RESULTS ON THIS INSPECTION, AND INTENDS TO SUBMIT A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.