MalfunctionIOY
SUPPORT ARM 176
Received Jan 23, 2023 · Event occurred Nov 18, 2021
Report 8010042-2023-00161 · MDR key 16224060
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 NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE SUPPORT ARM WAS REPORTEDLY BROKEN AT THE CLAMP ATTACHMENT AND WAS DISCARDED. PROVIDED PICTURE CONFIRMS THE REPORTED DAMAGE. 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).