inforMED
MalfunctionIOY

SUPPORT ARM 176

Received May 19, 2021 · Event occurred Apr 28, 2021

Report 8010042-2021-01116 · MDR key 11846999

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 176

Catalog number

6487800

Product problems

  • Fracture
  • Fracture

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

INVESTIGATION IS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE.

Description of Event or Problem

IT WAS REPORTED THAT THE VENTILATOR¿S SUPPORT ARM HOLDING THE PATIENT TUBES BROKE. PATIENT INVOLVEMENT IS UNKNOWN. (B)(4).