MalfunctionIOY
SUPPORT ARM 177
Received Sep 28, 2012
Report 8010042-2012-00110 · MDR key 2773842
Device
Manufacturer
Maquet Critical Care AbCatalog number
6481720
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B)(4).
Additional Manufacturer Narrative
THE BROKEN SUPPORT ARM WAS NOT RETURNED FOR INVESTIGATION. A PHOTO OF THE SUPPORT ARM SHOWED THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. WHILE WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE SUPPORT ARM BREAKING, OR THE AGE OF THE DEVICE, THIS TYPE OF PHYSICAL DAMAGE IS CONSISTENT WITH A CRACK, CAUSED BY OVERLOADING OR IMPACT, WHICH LED TO THE REPORTED BREAK. (B)(4).