BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS MEDICAL SYSTEMS FR2

    MDR report key: 547671 · Received October 7, 2004

    Report

    Report Number
    3030677-2004-00051
    Event Type
    Death
    Date Received
    October 7, 2004
    Date of Event
    August 4, 2004
    Report Date
    October 4, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS HEARTSTREAM
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DIALYSIS, THE PT WAS FOUND TO BE CYANOTIC. AFTER 10 MINUTES OF HEART MASSAGE, THE DEFIBRILATOR WAS BROUGHT TO THE PT'S SIDE. ALTHOUGH THE DEFIBRILLATOR ISSUED A SHOCK ADVISORY, A SHOCK WAS NOT DELIVERED. THE DEVICE INSTRUCTED THE USERS TO PRESS THE PADS FIRMLY TO THE CHEST (WHICH BY REPORT, THEY CHECKED THE PADS AND CONNECTIONS), THE DEVICE REANALYZED, ISSUED A SHOCK ADVISORY BUT AGAIN A SHOCK WAS NOT DELIVERED. BY REPORT, A NEW SET OF PADS WERE CONNECTED RESULTING IN THE SAME CYCLE OF ISSUING A SHOCK ADVISORY, THE SHOCK NOT BEING DELIVERED AND INSTRUCTING THE USER TO PRESS THE PADS OCCURRED THREE MORE TIMES BEFORE IT WAS TURNED OFF. NO ADVANCE LIFE-SAVING MEASURES WERE TAKEN, AND AN AMBULANCE THAT CARRIED A DEFIBRILLATOR WAS CALLED BUT THIS OTHER DEFBRILLATOR WAS NOT USED. IT WAS REPORTED THAT THE DEVICE SUBSEQUENTLY PASSED A SELF-TEST AND SUCCESSFULLY DELIVERED THREE SHOCKS INTO A PT SIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS FR2 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS HEARTSTREAM M3861A/M3841A *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death