BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18899835 · Received March 13, 2024

    Report

    Report Number
    3014342658-2024-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    April 15, 2022
    Report Date
    March 13, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IY WAS REPORTED THAT THE OR SOLUTIONS INC.ECOLAB ORS-2038D SOLUTION WARMER WAS FOUND TO BE DEFECTIVE. IT WAS SET ON A VERY LOW TEMPERATURE, BUT STILL MANAGE TO MELT THE PLASTIC DRAPES AND BURN THROUGH THEM. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455956 MICROTEK IRRIGATION SOLUTION WARMER LHC ECOLAB/MICROTEK INC ORS-2038D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown