inforMED
MalfunctionIOY

SUPPORT ARM 176

Received May 31, 2023 · Event occurred May 17, 2023

Report 8010042-2023-01039 · MDR key 17030783

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

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM 176 WAS BROKEN. THE EVALUATION OF THE PROVIDED PICTURES CONFIRMS THE BREAKAGE OF THE SUPPORT ARM. 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. OUR FIELD SERVICE ENGINEER (FSE) INSPECTED THE VENTILATOR ON SITE AND SOLVED THE ISSUE BY REPLACING THE SUPPORT ARM. PREVIOUS INVESTIGATIONS LED TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. THE REPORTED SUPPORT ARM WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS CHANGE. IT HAS BEEN CONFIRMED BY THE FSE THAT THE SUPPORT ARM IS OVER 20 YEARS OLD.

Description of Event or Problem

MANUFACTURERS REF: # (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM 176 WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).