SERVO-I
Received Aug 16, 2021 · Event occurred Jul 19, 2021
Report 8010042-2021-01986 · MDR key 12323597
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
INVESTIGATION IS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. 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. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE LOWER END. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).