BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SONIC CLEANER

    MDR report key: 770819 · Received August 22, 2006

    Report

    Report Number
    1043572-2006-00021
    Event Type
    Malfunction
    Date Received
    August 22, 2006
    Date of Event
    March 29, 2006
    Report Date
    August 22, 2006
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLG
    Removal / Correction Number
    1043572-6/17/06-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE TICKET STATES THAT UNIT WAS REPLACED WITH A NEW UNIT ON MAY 23, 2006.

    Description of Event or Problem · 1

    CUSTOMER SMELLED AN ELECTRICAL BURNING DOOR AND CALLED FACILITY'S ENGINEERING. EXTINGUISHED WITH A FIRE EXTINGUISHER. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SONIC CLEANER MEDICAL WASHER/DISINFECTOR FLG STERIS CORPORATION 1951373 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA