BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    MDR report key: 4122137 · Received September 19, 2014

    Report

    Report Number
    3030677-2014-02098
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE USER STATING THE DEVICE POWERED OFF DURING DEPLOYMENT. THE PT OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583350 HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS MEDICAL SYSTEMS 861389 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown