BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 1873501 · Received October 12, 2010

    Report

    Report Number
    1218950-2010-01933
    Event Type
    Death
    Date Received
    October 12, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE AS EXPECTED. THE RELATIONSHIP BETWEEN PT'S OUTCOME AND DEVICE'S BEHAVIOR IS UNK. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE AS EXPECTED. THE RELATIONSHIP BETWEEN PT'S OUTCOME AND DEVICE'S BEHAVIOR IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death