inforMED
MalfunctionIOY

SUPPORT ARM 176

Received Jan 18, 2024 · Event occurred Jan 11, 2024

Report 8010042-2024-00127 · MDR key 18534350

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 176

Catalog number

6405976

Product problems

  • Fracture
  • Fracture

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

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

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER. ACCORDING TO SERVICE REPORT THE SUPPORT ARM COULD NOT STAY IN POSITION WHEN HOLDING THE TUBES. ISSUE SOLVED BY REPLACING THE SUPPORT ARM. HOWEVER, NO PART RETURNED FOR INVESTIGATION. THEREFORE, NO ROOT CAUSE CAN BE ESTABLISHED.

Description of Event or Problem

MANUFACTURER'S REF. #: (B)(4).