inforMED
MalfunctionIOY

SUPPORT ARM 178

Received May 17, 2023 · Event occurred May 5, 2023

Report 8010042-2023-00955 · MDR key 16945691

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 178

Catalog number

6693715

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

BASED ON THE INFORMATION COLLECTED TO DATE, THE PROVIDED PROBLEM DESCRIPTION AND PHOTOS PROVIDED BY THE TECHNICIAN, IT HAS BEEN CLARIFIED THAT THE SUPPORT ARM WAS NOT DAMAGED BUT FELL OFF DUE TO THAT IT WAS MISSING THE CLAMP TO ATTACH THE ARM TO THE PNEUMATIC HANDLE. THE MENTIONED CLAMP IS AN ACCESSORY AND NEEDS TO BE ORDERED SEPARATELY. THERE IS NO INFORMATION HOW AND WHEN THE ISSUE OCCURRED. IT HAS BEEN CONCLUDED THAT THE ARM HAS BEEN OVERLOADED, AND SUBJECTED TO A FORCE GREATER THAT IT¿S BEEN MANUFACTURED TO SUSTAIN WHICH LED TO THAT THE SUPPORT ARM FELL OFF. H3 OTHER TEXT : 4112.

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM HAD FALLEN OFF. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.#: (B)(4).