inforMED
MalfunctionIOY

SUPPORT ARM 179

Received Feb 8, 2024 · Event occurred Jan 29, 2024

Report 8010042-2024-00260 · MDR key 18667379

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 179

Catalog number

6882001

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

IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT TUBES BROKE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF #: (B)(4).

Additional Manufacturer Narrative

BASED ON THE PROVIDED PROBLEM DESCRIPTION, PHOTOS, AND THE INFORMATION FROM THE CUSTOMER, IT HAS BEEN CLARIFIED THAT THE SUPPORT ARM HAS BEEN BROKEN. THE USER REPLACED THE DEFECTIVE PART AND PUT BACK THE UNIT FOR USAGE. ACCORDING TO SUPPORT ARM INSTALLATION INSTRUCTIONS, IN THE SPECIFICATION OF THE MAXIMUM CAPACITY, IT IS STATED HOW MANY KILOGRAMS CAN BE LOADED DEPENDING ON THE ANGLE OF USE OF THE ACCESSORIES (MAX. APPROX. 3 KG). THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.