BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3192466 · Received June 19, 2013

    Report

    Report Number
    1218950-2013-02476
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    May 24, 2013
    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 FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY WERE UNABLE TO BRING UP THE PULMONARY ARTERY PRESSURE (PAP) WAVEFORM AND NUMERICS ON THE DISPLAY. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279366 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1