BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3982597 · Received June 16, 2014

    Report

    Report Number
    1218950-2014-03431
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 22, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE READY FOR USE INDICATOR (RFU) DISPLAYED RED X WITH A CHIRP AND THE DEVICE INDICATED THAT SERVICE WAS NEEDED. THE DEVICE STATUS LOG CONTAINED AND ENTRY OF (LEADS) ECG BIAS - PROCESSOR PCA DATED AFTER THE LAST USER INITIATED OPERATIONAL CHECK WAS RUN WITH THE LEADS ECG TRUNK CABLE AND LEAD SETS ATTACHED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353554 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1