MalfunctionIOY
SUPPORT ARM 177
Received Sep 28, 2012
Report 8010042-2012-00111 · MDR key 2773844
Device
Manufacturer
Maquet Critical Care AbCatalog number
6481720
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B)(4).
Additional Manufacturer Narrative
THE BROKEN SUPPORT ARM WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER HAS INFORMED US THAT THE SUPPORT ARM WAS SCRAPPED AND THAT THEY DO NOT HAVE ANY FURTHER INFORMATION. WITH THE AVAILABLE INFORMATION THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. (B)(4).