SUPPORT ARM 176
Received Aug 23, 2022 · Event occurred Aug 2, 2022
Report 8010042-2022-01462 · MDR key 15274909
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 CIRCUIT BROKE. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
THE REPORTED ISSUE WITH BROKEN SUPPORT ARM WAS CONFIRMED DURING EVALUATION OF THE PROVIDED PICTURE AND IN PROBLEM DESCRIPTION. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE CLAMP ATTACHMENT. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. THE BROKEN SUPPORT ARM WAS NOT RETURNED TO US FOR FURTHER INVESTIGATION. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED. HOWEVER; THE BRAKING POINT INDICATES THAT IT MOST LIKELY HAS BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.