BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA

    MDR report key: 11612730 · Received April 5, 2021

    Report

    Report Number
    11612730
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    BSB
    UDI-DI
    10896128002449
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE AC ADAPTER OF THE BELMONT BUDDY LITE FLUID WARMER BECAME WET WITH BLOOD. WHILE TRYING TO CLEAN THE DEVICE, THE USER USED CAVICIDE AND SPRAYED THE AC ADAPTER WITHOUT UNPLUGGING IT FROM THE ELECTRICAL OUTLET, CAUSING A SHORT CIRCUIT ON THE POWER SUPPLY THAT GENERATED SPARKS AND SMOKE IN THE OPERATING ROOM (OR). THE OPERATING ROOM PROCEDURE WAS ALREADY COMPLETED AT THE TIME OF THE INCIDENT, NO PATIENT OR USER WERE HARMED BY THIS SITUATION. THE AC ADAPTER AND BELMONT BUDDY LITE WERE REMOVED FROM SERVICE. OPERATING ROOM LEADERSHIP CONDUCTED A PROCEDURE REVIEW WITH OPERATING ROOM PERSONNEL TO REVIEW PROPER CLEANING PROCEDURES OF EQUIPMENT THAT ARE CONTAMINATED WITH BIOLOGICAL FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513298 BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB BELMONT INSTRUMENT CORPORATION 905-00022 10896128002449

    Patients

    Seq Age Sex Outcome Treatment
    1