SUPPORT ARM 176
Received Feb 27, 2024 · Event occurred Feb 14, 2024
Report 8010042-2024-00374 · MDR key 18787821
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MANUFACTURER'S REF. #: (B)(4).
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER AND A PHYSICAL DAMAGE TO THE CLAP ATTACHMENT OF THE SUPPORT ARM WAS CONFIRMED. DAMAGED CLAMP ATTACHMENT ALSO CONFIRMED IN THE ATTACHED PHOTO. NO INFORMATION PROVIDED BY CUSTOMER ON WHAT CAUSED THE CLAMP ATTACHMENT TO BREAK. ISSUE RESOLVED BY REPLACING THE SUPPORT ARM AND THE VENTILATOR WAS HANDED OVER TO CUSTOMER IN WORKING CONDITION. THE ROOT CAUSE CAN NOT BE ESTABLISHED BY THIS INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).