BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 3901459 · Received June 19, 2014

    Report

    Report Number
    1218950-2014-03516
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 12, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 HEALTHCARE THAT THE PT REPORTED TISSUE BURN POST SUCCESSFUL SYNCHRONIZED CARDIOVERSIONS WITH A HEARTSTART XL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361826 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1