SUPPORT ARM 177
Received Nov 4, 2013
Report 8010042-2013-00220 · MDR key 3466272
Device
Manufacturer
Maquet Critical Care AbProduct problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
A PICTURE OF THE BROKEN SUPPORT ARM AND THE MANUFACTURING DATE INFO WERE RECEIVED. THIS INFO WAS ADEQUATE AND THEREFORE THE BROKEN SUPPORT ARM WAS NOT REQUESTED BACK. THE RECEIVED PICTURE SHOWED THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. INFO FROM THE HOSPITAL STATED THAT THE BREAKING OCCURRED DURING ADJUSTMENT AND THAT AT THE TIME THAT IT WAS NEITHER OVERLOADED NOR STRESSED. 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. PREVIOUS INVESTIGATION LED TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING (B)(4) 2009. THE BROKEN SUPPORT ARM WAS MANUFACTURED IN 2007 BEFORE IMPLEMENTATION OF THIS CHANGE. (B)(4).