inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Feb 10, 2021 · Event occurred Jan 12, 2021

Report 8010042-2021-00326 · MDR key 11311229

Device

Generic name

Support, Arm

Model number

SUPPORT ARM 177

Catalog number

6481720

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Unknown

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

NO REPAIR WAS REQUESTED AND NO PARTS WERE RETURNED. THE SUPPORT ARM WAS REPORTEDLY BROKEN AND COULD NOT BE REPAIRED. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED BUT MOST LIKELY HAS IT BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN. H3 OTHER TEXT : 4117.

Description of Event or Problem

MANUFACTURER'S REF #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM OF THE VENTILATOR BROKE. THE PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER REF.#: (B)(4).