inforMED
MalfunctionIOY

GCX

Received Jan 14, 2000 · Event occurred Jan 6, 2000

Report 258862 · MDR key 258862

Device

Generic name

Polymount Bracket

Manufacturer

Gcx Corporation

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Detachment Of Device Component
  • Component Falling
  • Design/structure problem
  • Material Separation
  • Sticking
  • Use of Device Problem

Patient

*

Narrative

Description of Event or Problem

GCX POLYMOUNT BRACKET SEPARATED WHEN SCREW FELL OUT AND A MONITOR WEIGHING APPROXIMATELY 55 POUNDS FELL. THE MONITOR WAS CAUGHT AND HELD BY A NURSE AND WAS ALSO HELD BY ONE ARM OF THE METAL BRACKET THAT WAS BENT BY THE WEIGHT OF THE MONITOR. THE SCREWS USED TO MOUNT THIS MONITOR WERE INSTALLED FLAT HEAD TOWARD THE BED. WHEN THE CAP STYLE BOLT ON TOP LOOSENS, THE SCREWS FALL OUT. THERE IS THE POTENTIAL TO CAUSE MAJOR PT HARM.