inforMED
MalfunctionLHC

FLUID WARMING AND SLUSH DRAPES

Received Dec 13, 2018 · Event occurred Dec 4, 2018

Report 8043817-2018-40016 · MDR key 8160567

Device

Generic name

Fluid Warming & Slush Drape

Model number

ORS-320

Lot number

D172411

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 DURING THE PROCEDURE, A HOLE WAS OBSERVED IN THE DRAPE. THE DRAPE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT