BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART XL

    MDR report key: 4102801 · Received September 11, 2014

    Report

    Report Number
    1218950-2014-05450
    Event Type
    Death
    Date Received
    September 11, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL DEFIBRILLATOR DID NOT DELIVER A SHOCK. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563234 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death