BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 3853671 · Received May 29, 2014

    Report

    Report Number
    1218950-2014-02983
    Event Type
    Death
    Date Received
    May 29, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 13, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING UNABLE TO TRANSITION PACING PATIENT FROM THE PARAMEDIC'S MONITOR/PACER TO THE EMERGENCY DEPARTMENT'S MONITOR/PACER. THE INVOLVED PATIENT DIED BUT THE CUSTOMER HAS STATED THAT THE DEVICE BEHAVIOR DID NOT IMPACT THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317373 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death