inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Mar 22, 2022

Report 8010042-2022-00508 · MDR key 13855100

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 177

Catalog number

6481720

Product problems

  • Fracture
  • Fracture

Patient

Unknown

  • 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. 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. PREVIOUS INVESTIGATIONS OF SIMILAR FAULTS LED TO A REDESIGN AND CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THE SUPPORT ARM ASSOCIATED WITH THIS COMPLAINT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION.

Description of Event or Problem

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