BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3022076 · Received March 26, 2013

    Report

    Report Number
    3015876-2013-00235
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CLINICAL EVALUATION WAS PERFORMED ON THE REPORTED EVENT AND THE INFORMATION AVAILABLE FROM THE EVENT. THE EVALUATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO USE ERROR. AFTER THE DEFIBRILLATION ENERGY WAS CHARGED, THE DEVICE USER PRESSED THE SPEED DIAL ON THE DEVICE, WHICH DISARMED THE ENERGY, INSTEAD OF PRESSING THE SHOCK BUTTON. WHEN THE SPEED DIAL IS PRESSED AFTER DEFIBRILLATION ENERGY IS CHARGED, IT IS NORMAL FOR THE DEVICE TO DISARM THE DEFIBRILLATION ENERGY. THE PATIENT'S ECG RHYTHM STILL SHOWED A SHOCKABLE WAVEFORM, BUT THE EMERGENCY MEDICAL STAFF DID NOT ATTEMPT TO DELIVER ANOTHER DEFIBRILLATION SHOCK FOR AN APPROXIMATE ADDITIONAL FOUR (4) MINUTES. PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY ANY DEVICE FAILURE WITH DELIVERING A DEFIBRILLATION SHOCK. THE DEVICE WAS FOUND TO BE FUNCTIONING NORMALLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, A (B)(6) CONSTRUCTION WORKER, WAS WORKING AND WENT INTO A WITNESSED CARDIAC ARREST. WHEN THE MEDICS ARRIVED, THE DEVICE WAS CONNECTED TO THE PATIENT AND A 200 JOULE SHOCK WAS CHARGED. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO SHOCK THE PATIENT AFTER THE DEVICE HAD CHARGED THE ENERGY. THEY CONTINUED PATIENT CARE AND LOADED THE PATIENT INTO THE AMBULANCE FOR TRANSPORT. APPROXIMATELY 4 MINUTES AND 23 SECONDS AFTER THE FIRST SHOCK WAS ATTEMPTED, THE CUSTOMER TRIED TO DELIVER ENERGY AND WAS ABLE TO CHARGE ENERGY AND SHOCK THE PATIENT THIS TIME. THE MEDICS ENDED UP DELIVERING THREE (3) DEFIBRILLATION SHOCKS TO THE PATIENT; HOWEVER, THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124515 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death