SUPPORT ARM 177
Received Apr 6, 2017 · Event occurred Mar 23, 2017
Report 8010042-2017-00149 · MDR key 6463301
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO PARTS WERE RETURNED. INVESTIGATION WAS BASED ON A PICTURE WE HAD RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING, OR IMPACT, AND THIS LED TO THE REPORTED BREAKING. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE LOWER END. THERE WAS NO PATIENT INVOLVEMENT REPORTED. (B)(4).