BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY CHARGER, SINGLE BAY

    MDR report key: 3901639 · Received May 6, 2014

    Report

    Report Number
    1222895-2014-00009
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    MOQ
    PMA / PMN Number
    K110582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 INFORMATION.

    Description of Event or Problem · 1

    DEALER INITIALLY REPORTED THAT WHEN YOU PLUG IT IN, IT SPARKS. (B)(6) 2014 OPERATING ROOM LEAD MANAGER REPORTS THE "BATTERY CHARGER FLICKERED/SPARKED TOWARD BACK OF THE DEVICE WHEN SHE PLUGGED IT IN." SHE IMMEDIATELY UNPLUGGED IT AND SENT IT OFF FOR REPAIR. NO HARM DONE, NOT IN PATIENT VICINITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271454 BATTERY CHARGER, SINGLE BAY LIGHTING MOQ INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1