SUPPORT ARM 177
Received Sep 28, 2012
Report 8010042-2012-00099 · MDR key 2773804
Device
Manufacturer
Maquet Critical Care AbCatalog number
6481720
Product problems
- Mechanical Problem
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. THE DATE STAMP ON THE SUPPORT ARM SHOWS THAT IT WAS MANUFACTURED IN 2007; THUS THE DEVICE IS FIVE YEARS OLD. WHILE WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE SUPPORT ARM BREAKING, THIS TYPE OF PHYSICAL DAMAGE IS CONSISTENT WITH A CRACK, CAUSED BY OVERLOADING OR IMPACT, WHICH LED TO THE REPORTED BREAK. SUBSEQUENT TO THE MANUFACTURE OF THIS DEVICE, PRODUCT ENHANCEMENTS WERE IMPLEMENTED TO INCREASE THE MECHANICAL STRENGTH OF THE SUPPORT ARMS. THE SUPPORT ARM WAS MANUFACTURED BEFORE IMPLEMENTATION OF THIS CHANGE. (B)(4).