BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 6135902 · Received November 30, 2016

    Report

    Report Number
    1218950-2016-07536
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    September 16, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ECG DATA ON SCREEN WITH NO PATIENT. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787366 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1