inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Sep 28, 2012

Report 8010042-2012-00112 · MDR key 2773845

Device

Catalog number

6481720

Product problems

  • Mechanical Problem

Patient

Not reported

  • No Patient Involvement

Narrative

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 INFO. WITH THE AVAILABLE INFO THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B)(4).