SUPPORT ARM 176
Received Feb 14, 2023 · Event occurred Jan 20, 2023
Report 8010042-2023-00331 · MDR key 16373265
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
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT TUBES BROKE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
THE SUPPORT ARM WAS REPAIRED BY OUR FIELD SERVICE ENGINEER AND WAS CLEARED FOR CLINICAL USE. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED. HOWEVER, THE BREAKING POINT INDICATES THAT IT MOST LIKELY HAS BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).