SUPPORT ARM 177
Received Feb 5, 2010 · Event occurred Jan 6, 2010
Report 8010042-2010-00011 · MDR key 1616559
Device
Manufacturer
Maquet Critical Care AbCatalog number
6481720
Product problems
- Component(s), broken
- Mechanical Problem
Patient
Not reported
- No Patient involvement
Narrative
Additional Manufacturer Narrative
PHOTOGRAPHIC 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 INTO 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 LEAD TO A RE-DESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS WAS IMPLEMENTED IN PRODUCTION DURING 05/2009. THE RETURNED SUPPORT ARM WAS MANUFACTURED DURING 2008. (B) (4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B) (4). (B) (4).