BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR2

    MDR report key: 1900339 · Received October 26, 2010

    Report

    Report Number
    3030677-2010-00342
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS REPORTED TO HAVE A BUTTON FAILURE. PENDING RETURN OF THE DEVICE FOR EVALUATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3860A-ABF

    Patients

    Seq Age Sex Outcome Treatment
    1