inforMED
MalfunctionLHC

ECOALB -

Received Mar 23, 2020 · Event occurred Feb 19, 2020

Report 1043582-2020-00002 · MDR key 9867988

Device

Generic name

Slush + Warmer Disc-drape, 66" X 44"

Model number

ORS-320

Product problems

  • Material Puncture/Hole
  • Material Puncture/Hole

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A WHOLE WAS FOUND NEAR THE PLATE OF THE WARMING DRAPE. THE CUT WAS FOUND PRIOR TO USE ON ANY PATIENT.