MalfunctionLHC
MEDLINE-MICROTEK
Received Feb 22, 2025 · Event occurred Dec 17, 2024
Report 3013401749-2025-00002 · MDR key 21441580
Device
Generic name
Irrigation Solution Warmer, 3.8 Liter
Manufacturer
Microtek Medical LlcModel number
ORS-2038DProduct problems
- Leak/Splash
- Material Puncture/Hole
- Leak/Splash
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ONE UNIT OF ORS-2038D OVERHEATED CAUSING A DRAPE BURN AND LEAK. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.