MalfunctionIOY
SUPPORT ARM 177
Received Sep 5, 2014
Report 8010042-2014-00396 · MDR key 4098773
Device
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. THERE WAS NO PT INVOLVEMENT. (B)(4).
Additional Manufacturer Narrative
THE BROKEN SUPPORT ARM WAS NOT RETURNED FOR INVESTIGATION. INFO WAS RECEIVED THAT THE CUSTOMER SCRAPPED THE BROKEN SUPPORT ARM AFTER THE REPLACEMENT. NO FURTHER INFO REGARDING THE EVENT HAS BEEN RECEIVED. WITH AVAILABLE INFO, THE CAUSE TO THE EVENT CANNOT BE DETERMINED. (B)(4).