inforMED
MalfunctionIOY

SUPPORT ARM 176

Received May 23, 2022 · Event occurred May 3, 2022

Report 8010042-2022-00875 · MDR key 14468209

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 176

Catalog number

6405976

Product problems

  • Fracture
  • Fracture

Patient

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 CIRCUIT BROKE. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).

Additional Manufacturer Narrative

THE SUPPORT ARM WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE SUPPORT ARM WAS REPORTEDLY BROKEN AT THE CLAMP ATTACHMENT. THE SUPPORT ARM WAS NOT RETURNED FOR INVESTIGATION AND NO PICTURES OF THE DAMAGES WERE PROVIDED.THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED BUT MOST LIKELY HAS IT BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.