BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1052196 · Received May 21, 2008

    Report

    Report Number
    3023750-2008-00132
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D BUT ITS RETURN IS ANTICIPATED. UPON RETURN AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE LOW BATTERY INDICATOR WAS FLASHING ON THE DEVICE. THEY TRIED TO TURN THE UNIT ON BUT IT WOULD NOT INITIALIZE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED 10

    Patients

    Seq Age Sex Outcome Treatment
    1