SUPPORT ARM 176
Received Feb 11, 2015 · Event occurred Jan 23, 2015
Report 8010042-2015-00048 · MDR key 4524235
Device
Manufacturer
Maquet Critical Care AbCatalog number
6405976
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE PART HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative
THE BROKEN SUPPORT ARM WAS RECEIVED BACK FOR INVESTIGATION, WHEREIN VISUAL INSPECTION OF THE SUPPORT ARM CONFIRMED THE REPORTED CRACKS. THE SUPPORT ARM WAS MANUFACTURED IN AUGUST OF 2002. THE POSITION OF THE BREAK INDICATES THAT THE SUPPORT ARM HAD VEEN OVERLOADED, HOWEVER, THE TRUE CAUSE FOR THE BROKEN SUPPORT ARM/ HAS/CAN NOT BE DETERMINED FROM THIS INVESTIGATION. THE SUPPORT ARM IS DESIGNED AND TESTED ACCORDING TO THE STANDARD EN 60601-01.
Description of Event or Problem
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM HAD CRACKS. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).