MalfunctionIOY
SUPPORT ARM 177
Received Sep 19, 2014
Report 8010042-2014-00425 · MDR key 4122038
Device
Manufacturer
Maquet Critical Care AbCatalog number
6481720
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO PARTS ARE AVAILABLE FOR INVESTIGATION SINCE THEY WERE SCRAPPED BY THE CUSTOMER. DUE TO THIS FACT, THE ROOT CAUSE OF THE BREAKAGE CANNOT BE ESTABLISHED. ACCORDING TO THE RECEIVED INFO THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. NO INFO REGARDING MANUFACTURING DATE OF THE SUPPORT ARM HAS BEEN RECEIVED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARE BROKE. THERE WAS NO PT INVOLVEMENT. (B)(4).