BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1673549 · Received April 30, 2010

    Report

    Report Number
    3015876-2010-00558
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    March 27, 2010
    Report Date
    April 1, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): PHYSIO-CONTROL EVALUATED THE DEVICE; HOWEVER, THE REPORTED FAILURE WAS NOT DUPLICATED. PROPER DEVICE OPERATION WAS OBSERVED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED FAILURE HAS NOT BEEN DETERMINED. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT DEVICE USE MAY HAVE CONTRIBUTED TO THE PT'S OUTCOME. THE ECG WAVEFORMS INDICATE A SHOCKABLE RHYTHM; HOWEVER, PROVISION WAS DELAYED AS REPORTED BY 6 MINUTES. THERE IS ALSO INDICATION OF A POSSIBLE USER ERROR. THE CONTINUOUS ECG OF THE TWO RECORDS FOR THE SAME PT DOCUMENTS A "POWER OFF" ANNOTATION, WHICH IS PRECEDED BY 5-7 SECONDS OF NO ECG DATA. THIS IS TYPICAL OF THE SHUT DOWN PROCESSING WHEN THE ON/OFF BUTTON IS PRESSED AND THE DEVICE POWERS DOWN, THIS INDICATES THAT THE USER MAY HAVE PRESSED THE ON/OFF BUTTON INSTEAD OF THE SHOCK BUTTON, TURNING OFF THE DEVICE.

    Description of Event or Problem · 1

    DURING A RESUSCITATION ATTEMPT OF A PT, THE DEVICE WAS USED IN THE AED MODE. IT WAS REPORTED THAT WHEN THE SHOCK BUTTON WAS PRESSED, THE DEVICE TURNED ITSELF OFF. A SECOND ATTEMPT TO SHOCK THE PT WAS INITIATED AND, AFTER THE AED ANALYSIS AND SHOCK ADVISED, THE DEVICE TURNED ITSELF OFF AGAIN. THE DEFIBRILLATION OF THE PT WAS DELAYED FOR 6 MINUTES UNTIL A SECOND CREW ARRIVED WITH ANOTHER DEFIBRILLATOR, THE PT 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 75 YR Death