BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3, REFURB ECG AED, LANGUAGE CONFIGURAB

    MDR report key: 8704410 · Received June 17, 2019

    Report

    Report Number
    3030677-2019-01271
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    June 10, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE STATUS INDICATOR IS NOT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497180 FR3, REFURB ECG AED, LANGUAGE CONFIGURAB AED MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1