BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3888202 · Received June 23, 2014

    Report

    Report Number
    3015876-2014-00683
    Event Type
    Death
    Date Received
    June 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 28, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED DEVICE FAILURE. THE DEVICE WAS FOUND TO BE FUNCTIONING NORMALLY. THE ELECTRONIC PATIENT EVENT RECORD WAS DOWNLOADED FROM THE DEVICE AND EVALUATED. THE PATIENT EVENT RECORD INDICATES THAT ALL NINE OF THE ECG ANALYSES PERFORMED BY THE DEVICE RESULTED IN A ¿SHOCK ADVISED¿ DECISION AND THE DEFIBRILLATOR CHARGED EACH TIME IN PREPARATION FOR A SHOCK TO BE ADMINISTERED AFTER 15 SECONDS OF PRE-SHOCK CPR HAD BEEN COMPLETED (THE DEVICE IS CONFIGURED TO PROMPT 15 SECONDS OF PRE-SHOCK CPR TIME); HOWEVER, ONLY THE FIRST TWO SHOCKS WERE ADMINISTERED TO THE PATIENT. THE DEFIBRILLATOR CHARGE WAS AUTOMATICALLY DISARMED 15 SECONDS AFTER THE DEFIBRILLATOR GAVE THE ¿PUSH SHOCK BUTTON¿ PROMPT FOR THE LAST SEVEN ¿SHOCK ADVISED¿ DECISIONS. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO A USE ERROR. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED A PHYSIO-CONTROL FIELD SERVICE REPRESENTATIVE (FSR) TO REPORT THAT THEIR DEVICE DID NOT RESPOND PROPERLY DURING A PATIENT EVENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS STATING "SHOCK ADVISED" APPROXIMATELY 20-30 SECONDS AFTER CPR WAS STARTED. THE PATIENT WAS A MALE IN HIS 70'S WITH A CARDIAC HISTORY. THE FIRE DEPARTMENT ARRIVED FIRST AND DELIVERED ONE SHOCK USING THEIR AED (UNKNOWN MODEL). THE CUSTOMER'S DEVICE WAS THEN USED TO ANALYZE THE PATIENT¿S ECG RHYTHM IN THE AED MODE AND THEY SUCCESSFULLY DELIVERED TWO SHOCKS. THE CUSTOMER MAINTAINS THE DEVICE WOULD THEN SAY "NO SHOCK ADVISED" ON SUBSEQUENT ECG ANALYSES AND AFTER 20-30 SECONDS THE DEFIBRILLATOR WOULD START TO CHARGE. THEY LET THE CHARGE DUMP EACH TIME THIS OCCURRED FOR THE REMAINDER OF THE DEVICE USE. AN AMBULANCE ALS CREW ARRIVED OVER 10 MINUTES LATER AND APPLIED THEIR MONITOR (UNKNOWN MODEL). THIS DEVICE SHOWED A POSSIBLE FINE VENTRICULAR FIBRILLATION RHYTHM AND THE ALS CREW SHOCKED THE PATIENT ONCE WHILE ADMINISTERING DRUGS. THE PATIENT WAS THEN DIAGNOSED IN PEA AND ASYSTOLE. THE PATIENT WAS THEN CALLED AS DECEASED LATER IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365905 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death