SUPPORT ARM 177
Received Mar 3, 2016
Report 8010042-2016-00114 · MDR key 5476244
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2016 11:45 AM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): IT WAS REPORTED THAT THE SUPPORT ARM WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION OF THE RETURNED SUPPORT ARM HAS BEEN FINALIZED. IT WAS REPORTED THAT THE SUPPORT ARM WAS FOUND BROKEN BY OUR SERVICE ENGINEER ON ANOTHER ASSIGNMENT DURING A SERVICE VISIT AT SITE. VISUAL INSPECTION SHOWS THAT THERE IS A CLEAR RUPTURE AND IN THE MICROSCOPIC INVESTIGATION THE CONCLUSION IS THAT THERE IS NO CASTING DEFECT. THIS IMPLIES THAT THE SUPPORT ARM HAS BEEN EXPOSED TO A MECHANICAL FORCE THAT'S ABOVE THE DESIGNED SPECIFICATION. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGN ACCORDING TO STANDARD. IT¿S UNKNOWN TO US UNDER WHICH CONDITIONS THE REPORTED SUPPORT ARM BROKE.
Description of Event or Problem
(B)(4).