SUPPORT ARM 176
Received Dec 15, 2009 · Event occurred Jul 29, 2009
Report 8010042-2009-00267 · MDR key 1568463
Device
Manufacturer
Maquet Critical Care AbCatalog number
6405976
Product problems
- Component(s), broken
- Mechanical Problem
Patient
Not reported
- No Patient involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B) (4). (B) (4).
Additional Manufacturer Narrative
IMAGES OF THE REPORTED SUPPORT ARM HAVE BEEN RECEIVED AND EVALUATED. THE IMAGES SHOW THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. BASED ON PRIOR INVESTIGATIONS OF SIMILAR FAULTS, OUR CONCLUSION IN THIS MATTER IS THAT THE SUPPORT ARM HAS BEEN OVERLOADED, STRESSED TO FORCES EXCEEDING THE LIMITS STATED IN THE INSTALLATION INSTRUCTIONS. PRIOR PERFORMED INVESTIGATIONS HAVE LED TO A RE-DESIGN AND A CHANGE OF THE MFG PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS WAS IMPLEMENTED IN PRODUCTION DURING MAY 2009. THE REPORTED SUPPORT ARM WAS MFG DURING SEPT 1998. (B) (4).