SUPPORT ARM
Received Dec 21, 2020 · Event occurred Dec 10, 2020
Report 8010042-2020-01275 · MDR key 11044791
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT HOSES WAS DAMAGED. THE EVALUATION OF THE RECEIVED PICTURE SHOWS THAT THE SUPPORT ARM HAS BROKEN DIRECTLY AT THE JOINT OF THE ARM. THE ARM WAS NOT RETURNED FOR INVESTIGATION. THE SUPPORT ARM IS A CASTING AND IT PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. THE REPORTED VENTILATOR WAS MANUFACTURED IN OCTOBER 2009, WHY IT IS LIKELY THAT THIS ARM WAS MANUFACTURED BEFORE THE PRODUCTION CHANGE.
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT HOSES WERE DAMAGED. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).