SUPPORT ARM 177
Received Nov 6, 2020
Report 8010042-2020-00919 · MDR key 10800219
Device
Generic name
Support, Arm
Manufacturer
Maquet Critical Care AbModel number
SUPPORT ARM 177Catalog number
6481720
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT REQUEST SERVICE, AND REPLACED THE BROKEN SUPPORT ARM BY THEMSELVES. NO PICTURES OR PARTS WERE RECEIVED FOR FURTHER INVESTIGATION 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. HOWEVER, SINCE NO PICTURES, OR PARTS PROVIDED FOR OUR INVESTIGATION, THE ROOT CAUSE OF THE BROKEN SUPPORT CAN NOT BE ESTABLISHED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM OF THE VENTILATOR WAS DAMAGED. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).