BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOLAB

    MDR report key: 14429912 · Received May 18, 2022

    Report

    Report Number
    14429912
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 26, 2022
    Manufacturer
    OR SOLUTIONS INC
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606039 ECOLAB WARMER, IRRIGATION SOLUTION LHC OR SOLUTIONS INC ORS-2038D

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Male