SUPPORT ARM 176
Received Feb 21, 2023 · Event occurred Jan 5, 2023
Report 8010042-2023-00377 · MDR key 16408049
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 INVESTIGATION OF THE REPORTED ISSUE HAS BEEN FINALIZED. IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM USED FOR HOLDING THE PATIENT CIRCUIT BROKE. PATIENT INVOLVEMENT IS UNKNOWN. THE REPORTED ISSUE WITH BROKEN PART WAS CONFIRMED IN PROBLEM DESCRIPTION AND ADDITIONAL INFORMATION, WHERE IT WAS STATED THAT 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.
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM USED FOR HOLDING THE PATIENT CIRCUIT BROKE. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).