SUPPORT ARM 176
Received Jan 8, 2021 · Event occurred Dec 14, 2020
Report 8010042-2021-00014 · MDR key 11138932
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 176Catalog number
6405976
Product problems
- Break
- Break
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
MANUFACTURER'S REF #: (B)(4).
Additional Manufacturer Narrative
THE EVALUATION OF THE RETURNED PICTURE SHOWS THAT THE SUPPORT ARM BROKE AT THE BRACKET. THE SUPPORT ARM BRACKET IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR AN IMPACT EXCEEDING THE LIMITS STATED IN THE INSTALLATION INSTRUCTIONS. IF THE SUPPORT ARM WOULD BREAK DURING PATIENT TREATMENT IT COULD IN WORST CASE LEAD TO EXTUBATION AND/OR INJURY. 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 AGE OF THE SUPPORT ARM IS UNKNOWN, BUT THE CONNECTED VENTILATOR WAS MANUFACTURED IN THE YEAR 2006. THE REPORTED SUPPORT ARM IS MOST LIKELY MANUFACTURED DURING THE SAME TIME PERIOD, BEFORE THE IMPLEMENTATION OF THE MANUFACTURING CHANGE.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM WAS DAMAGED. THE PATENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).