SUPPORT ARM 177
Received Jan 8, 2021 · Event occurred Dec 21, 2020
Report 8010042-2021-00006 · MDR key 11138374
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 177Catalog number
6481720
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO PARTS WERE RETURNED. THE BROKEN SUPPORT ARM WAS DISCARDED BY THE USER FACILITY. 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. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. 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 SUPPORT ARM ASSOCIATED WITH THIS COMPLAINT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE LOWER END. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).