inforMED
MalfunctionIOY

SUPPORT ARM 177

Received May 16, 2013

Report 8010042-2013-00076 · MDR key 3126589

Device

Product 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).