MalfunctionIOY
SUPPORT ARM 176
Received Apr 20, 2022 · Event occurred Mar 30, 2022
Report 8010042-2022-00697 · MDR key 14159387
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUPPORT ARM WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. A BREAKAGE AT THE JOINT NEAREST TO THE BRACKET WAS FOUND. THE SUPPORT ARM 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).