inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Nov 4, 2013 · Event occurred Oct 9, 2013

Report 8010042-2013-00219 · MDR key 3574064

Device

Model number

NA

Catalog number

6481720

Lot number

NA

Product problems

  • Mechanical Problem

Patient

NA

  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

THE BROKEN SUPPORT ARM HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM BROKE. THERE WAS NO PT INVOLVEMENT. (B)(4).