inforMED
MalfunctionLHC

FLUID WARMING AND SLUSH DRAPE

Received Jun 3, 2019 · Event occurred May 23, 2019

Report 8043817-2019-40022 · MDR key 8663230

Device

Generic name

Warmer Drape, Irrigation Solution

Manufacturer

Ecolab

Model number

ORS-100

Lot number

UNKNOWN

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 DRAPE PINHOLE WAS OBSERVED PRIOR TO USE. THE DRAPE WAS REPLACED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.