BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3850178 · Received June 5, 2014

    Report

    Report Number
    3015876-2014-00618
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CUSTOMER REPORTED THAT THE DEVICE USER(S) HAD NOT BEEN TRAINED ON THE USE OF THE DEVICE OR ON CARDIAC ARREST RESUSCITATION TECHNIQUES. THE CUSTOMER REPORTED THAT THE DEVICE USER(S) WERE STRESSED AND CONFUSED AND HAD INADVERTENTLY TURNED THE DEVICE OFF INSTEAD OF PRESSING THE SHOCK BUTTON TO DELIVER THE DEFIBRILLATOR SHOCK. THE DOWNLOADED PATIENT EVENT RECORDS FROM THE DEVICE ALSO INDICATE THAT THE DEVICE USER PRESSED THE DEVICE ON/OFF BUTTON AND TURNED THE DEVICE OFF EACH TIME WITHIN APPROXIMATELY 2 SECONDS AFTER A SHOCK WAS ADVISED. THE DEVICE WAS TURNED OFF BEFORE THE DEFIBRILLATOR HAD A CHANCE TO CHARGE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO USE ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS POWERED OFF BY THE USER TWICE DURING USE ON A (B)(6) MALE BEING TREATED FOR CARDIAC ARREST. THE ELECTRODES WERE CONNECTED, THE DEVICE ANALYZED THE PATIENT'S RHYTHM AND PROMPTED ¿SHOCK ADVISED¿. IT WAS REPORTED THAT THE USER PUSHED THE WRONG BUTTON TO DELIVER THE SHOCK AND POWERED OFF THE DEVICE. THE DEVICE WAS POWERED BACK ON APPROXIMATELY 4 MINUTES LATER, THE PATIENT¿S ECG RHYTHM WAS ANALYZED AND A SHOCK WAS ADVISED. THE USER AGAIN PUSHED THE WRONG BUTTON AND SWITCHED THE DEVICE OFF. THE HOSPITAL RESUSCITATION TEAM SUBSEQUENTLY ARRIVED AND, USING ANOTHER DEFIBRILLATOR, ADMINISTERED SHOCKS TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL CATH LAB AND AN ATTEMPT WAS MADE TO PLACE A CATHETER, HOWEVER THE PATIENT'S POSTERIOR CORONARY ARTERY WAS COMPLETELY BLOCKED. THE PATIENT DID NOT SURVIVE. THE PATIENT HAD BEEN EXERCISING IN THE HOSPITAL SPORTS FACILITY WHEN THE CARDIAC ARREST OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329633 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death