SUPPORT ARM 177
Received May 16, 2013
Report 8010042-2013-00076 · MDR key 3126589
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
ONLY PART OF THE SUPPORT ARM WAS RETURNED. THE PART THAT WAS RETURNED WAS THE LOWEST PIVOT ARM AND IT WAS BROKEN IN THE ARTICULATING JOIN. VISUAL INSPECTION SHOWED THAT THE BROKEN SECTION WAS POROUS. THE RETURNED PART DID NOT INCLUDE DATE STAMP BUT ACCORDING TO THE CUSTOMER IT WAS PURCHASED IN 2005. THE CUSTOMER STATED THAT SUPPORT ARMS ARE NOT OVERLOADED OR USED TO PULL VENTILATORS DURING TRANSPORT BUT STATED THAT SOMETIMES THE SUPPORT ARMS "TOUCH" THE LARGE STANDS. THIS CAN IMPLY THAT IMPACTS OCCUR. 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 INVESTIGATIONS LED TO A REDESIGN AND A CHANGE OF MFG PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING (B)(6) 2009. THE SUPPORT ARM IN THIS REPORT WAS MANUFACTURED BEFORE IMPLEMENTATION OF THIS CHANGE. (B)(4).