inforMED
MalfunctionIOY

SUPPORT ARM 179

Received Dec 16, 2022 · Event occurred Nov 11, 2022

Report 8010042-2022-02236 · MDR key 15994606

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 179

Catalog number

6882001

Product problems

  • Fracture
  • Fracture

Patient

Prefer Not To Disclose

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE SUPPORT ARM WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER ON-SITE AND WAS IDENTIFIED DEFECTIVE. THE SUPPORT ARM WAS NOT RETURNED TO MANUFACTURER FOR TECHNICAL INVESTIGATION. THE CAUSE OF THE REPORTED COMPONENT FAILURE HAS NOT BEEN ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED THAT THE FIXING BRACKET OF THE SUPPORT ARM FAILED AND COULD NOT BE FIXED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).