MalfunctionIOY
SUPPORT ARM 176
Received Nov 2, 2021 · Event occurred Oct 20, 2021
Report 8010042-2021-02629 · MDR key 12735628
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO SERVICE WAS REQUESTED. THE SUPPORT ARM WAS REPLACED BY THE USER FACILITY AND NOT RETURNED FOR INVESTIGATION. NO PICTURES ON THE DAMAGES WERE PROVIDED. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED BUT MOST LIKELY HAS IT BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT CIRCUIT BROKE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).