inforMED
MalfunctionIOY

SUPPORT ARM 179

Received Dec 17, 2021

Report 8010042-2021-02979 · MDR key 13024042

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

NO REPAIR WAS REQUESTED AND NO PARTS WERE RETURNED. PICTURES WERE PROVIDED SHOWING THE FIXATION PLATE ON THE RAIL CLAMP THAT IS USED FOR FIXATING THE SUPPORT ARM ON THE VENTILATOR¿S SIDE RAIL HAD FALLEN OFF. 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.

Description of Event or Problem

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