SUPPORT ARM 177
Received Apr 22, 2016 · Event occurred Feb 8, 2016
Report 8010042-2016-00224 · MDR key 5597818
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT ONE OF THE JOINTS. THERE WAS NO PATIENT HARM REPORTED. (B)(4).
Additional Manufacturer Narrative
OUR INVESTIGATION INTO THIS COMPLAINT HAS NOW BEEN FINALIZED. IT WAS REPORTED THAT A SUPPORT ARM FOR A VENTILATOR BROKE AT ONE OF THE JOINTS. RECEIVED PICTURES OF THE BROKEN SUPPORT ARM CONFIRMED THE EVENT DESCRIPTION. OUR EVALUATION OF THE RECEIVED PICTURES SHOWED THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. 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 BREAKAGE. PREVIOUS INVESTIGATIONS OF SIMILAR FAULTS LED TO A REDESIGN AND CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THE DATE STAMP SHOWED THAT THE SUPPORT ARM ASSOCIATED WITH THIS COMPLAINT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION.
Description of Event or Problem
(B)(4).