SUPPORT ARM 177
Received Oct 22, 2021 · Event occurred Oct 20, 2021
Report 8010042-2021-02554 · MDR key 12679997
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUPPORT ARM WAS REPLACED BY OUR FIELD SERVICE ENGINEER BUT NOT RETURNED FOR INVESTIGATION. PROVIDED PICTURES CONFIRMED THE REPORTED BREAKAGE. 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 BROKE AT THE LOWER END. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).