SUPPORT ARM 177
Received Mar 18, 2016
Report 8010042-2016-00152 · MDR key 5510245
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
OUR INVESTIGATION INTO THIS COMPLAINT HAS NOW BEEN FINALIZED. NO PARTS OR PICTURES WERE RETURNED FOR OUR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SUPPORT ARM WILL NOT REMAIN IN ITS INTENDED/DESIRED POSITION. OUR CONCLUSION IS, THAT THE FRICTION IN THE JOINT HAS BEEN REDUCED, MOST LIKELY DUE TO WEAR. THERE WAS/IS NO EVIDENCE TO SUPPORT A MECHANICAL BREAK OF THE DEVICE. THERE ARE SERVICE KITS AVAILABLE FOR EXCHANGING PARTS OF THE JOINTS WHEN THEY BECOME WORN OUT.
Description of Event or Problem
(B)(4).
Description of Event or Problem
(B)(6) 2016 09:00 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): IT WAS REPORTED THAT THE SUPPORT ARM FOR THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. (B)(4).