BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY CHARGER, SINGLE BAY

    MDR report key: 3902753 · Received May 9, 2014

    Report

    Report Number
    1222895-2014-00008
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 25, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    EBZ
    PMA / PMN Number
    K110582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE BATTERY CHARGER DEVICE WAS NOT PLUGGED IN SO RN PLUGGED IN TO WALL, THEN THE UNIT EXPERIENCED A LARGE FLASH AND A BUZZING SOUND FROM THE CHARGING UNIT. DATE: (B)(6) 2014 CLINICAL SUPERVISOR REPORTS THAT EVENT OCCURRED IN THE EQUIPMENT ROOM AND NO HARM TO PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281522 BATTERY CHARGER, SINGLE BAY LIGHTING EBZ INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1