BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1012523 · Received March 12, 2008

    Report

    Report Number
    3015876-2008-00167
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 13, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT THE PATIENT'S DEATH WAS DUE TO DEVICE USE ERROR. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE USER CONFIGURABLE DISPLAY CONTRAST CONTROL WAS SET TO THE DARKEST SETTING. THE DISPLAY CONTRAST CONTROL WAS RESET TO MAKE THE DISPLAY VISIBLE. THE DEVICE WAS OBSERVED TO OPERATED PROPERLY THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND IT WAS RETURNED TO THE CUSTOMER FOR USE. ADJUSTING THE DEVICE CONTRAST CONTROL AS REVIEWED WITH THE CUSTOMER.

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A PERSON IN AN APARTMENT WITH CHEST PAINS AND FIRST RESPONSE EMT'S ALREADY ON THE SCENE. THE DEVICE WAS CONNECTED TO THE PATIENT WITH ECG LEADS AND DEFIBRILLATION ELECTRODES BUT, ACCORDING TO THE REPORTER, WHEN THE PARAMEDICS TURNED ON THE DEVICE, THE DISPLAY SCREEN WAS DARK GREY AND WOULDN'T DISPLAY THE PATIENT'S RHYTHM. THE CREW ATTEMPTED TROUBLESHOOTING METHODS AND CYCLED POWER SEVERAL TIMES WITHOUT SUCCESS. THE CREW NOTED THAT ECG AND DEFIBRILLATOR ELECTRODES MADE GOOD CONTACT WITH THE PATIENT. THE PARAMEDIC AND EMT CREWS MOVED THE PATIENT DOWNSTAIRS AND LOADED HER INTO THE AMBULANCE AND THE PARAMEDIC CREW BEGAN TRANSPORT TO THE HOSPITAL. DURING TRANSPORT, THE PATIENT BECAME UNRESPONSIVE, THEN FURTHER DETERIORATED AND WENT INTO CARDIAC ARREST. THE REPORT STATES THAT THE PARAMEDICS DID NOT USE THE DEVICE TO DEFIBRILLATE THE PATIENT BECAUSE THE SCREEN WAS DARK AND THE AED HAD LEFT WITH THE FIRST RESPONSE ENGINE AND WAS UNAVAILABLE TO THE PARAMEDIC CREW. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death