SUPPORT ARM 177
Received Oct 24, 2015 · Event occurred Sep 1, 2015
Report 8010042-2015-01045 · MDR key 5174047
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OCTOBER 23, 2015 01:18 PM (GMT-4:00) ADDED BY (B)(6): EVALUATION OF RETURNED PHOTOGRAPHS SHOWS 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 BREAKING. PREVIOUS INVESTIGATIONS LED TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. THE DATE STAMP ON THE REPORTED SUPPORT ARM SHOWS THAT IT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS CHANGE.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR THE VENTILATOR BROKE WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT. THERE WAS NO PATIENT HARM. (B)(4).