MalfunctionLHC
FLUID WARMING AND SLUSH DRAPES
Received Dec 10, 2018 · Event occurred Oct 28, 2018
Report 8043817-2018-40015 · MDR key 8147125
Device
Generic name
Fluid Warming & Slush Drape, Product Code: Lhc
Manufacturer
Ecolab / Microtek Dominicana, S.a.Model number
ORS-320Lot number
D182129
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 WHEN FLUID WAS LEAKING THROUGH THE DRAPE. THE DRAPE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT