MalfunctionLHC
DRAPE EQUIPMENT SLUSH MACHINE DISK WARMER
Received May 31, 2019 · Event occurred May 20, 2019
Report 8043817-2018-00020 · MDR key 8660420
Device
Generic name
Fluid Warming & Slush Drapes
Manufacturer
Ecolab / Microtek Dominicana, S.aModel number
ORS-300Lot number
D190259
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 A PROCEDURE, A HOLE WAS OBSERVED IN THE DRAPE. THE DRAPE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.