BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 2910367 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00032
    Event Type
    Death
    Date Received
    January 7, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR "FLOW WAS LOW" DURING A RESUSCITATION EFFORT. THE INVOLVED PT DIED. THE COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR "FLOW WAS LOW" DURING A RESUSCITATION EFFORT. THE INVOLVED PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6778 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A US00581574

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death