SUPPORT ARM 177
Received Jul 24, 2017
Report 8010042-2017-00343 · MDR key 6735764
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE FACILITY HAD DISCARDED THE SUPPORT ARM THEREFORE THE POINT OF BREAK WAS NOT VERIFIED. NO INVESTIGATION HAS BEEN POSSIBLE AND THE TRUE CAUSE OF BREAKAGE OF THE SUPPORT ARM HAS NOT BEEN DETERMINED.
Description of Event or Problem
WHILE A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON ANOTHER ISSUE, THE FACILITY STAFF ALSO INFORMED THE FSE THAT A SUPPORT ARM HAD BROKEN. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Additional Manufacturer Narrative
THE REPORTED SUPPORT ARM WAS SCRAPPED BY THE CUSTOMER, NO PICTURES OR GOODS ARE AVAILABLE FOR INVESTIGATION. THE CAUSE TO WHY OR HOW THE REPORTED SUPPORT ARM BROKE CANNOT BE ESTABLISHED.
Description of Event or Problem
(B)(4).