SUPPORT ARM 178
Received May 28, 2024 · Event occurred Apr 4, 2024
Report 8010042-2024-00859 · MDR key 19404425
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 178Catalog number
6693715
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON TECHNICIAN STATEMENT, THE THERE IS NO INFORMATION HOW THE BREAKAGE OCCURRED. ACCORDING TO THE PROVIDED PHOTO, THE SUPPORT ARM BROKE ON THE LOCKING JOINT. THE WHOLE SUPPORT ARM HAS BEEN REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO STOP OF VENTILATION (EXTUBATION) OR INJURY. ACCORDING TO INSTALLATION INSTRUCTIONS FOR SUPPORT ARM 178 (REV.01), THE MAXIMUM LOAD OF THE ARM IS IN RANGE BETWEEN 1 TO 3 KG DEPENDS ON THE ANGLE OF USE OF THE ACCESSORIES. IT REMAINS UNKNOWN IF THE SUPPORT ARM HAS BEEN OVERLOADED. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FELL OFF. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).