MalfunctionIOY
SUPPORT ARM 176
Received Nov 1, 2021 · Event occurred Oct 6, 2021
Report 8010042-2021-02619 · MDR key 12726802
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUPPORT ARM WAS REPLACED BY OUR FIELD SERVICE ENGINEER BUT WAS NOT RETURNED FOR INVESTIGATION. 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. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).