BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3727799 · Received April 4, 2014

    Report

    Report Number
    3015876-2014-00365
    Event Type
    Death
    Date Received
    April 4, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BIOMEDICAL ENGINEER AT THE CUSTOMER'S FACILITY EXAMINED THE DEVICE AND FOUND NO ISSUES WITH THE DEVICE'S ABILITY TO POWER ON AND DEFIBRILLATE. THE DEVICE HAS BEEN RETURNED TO PHYSIO-CONTROL'S FOR EVALUATION. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO THEN COMPLETED UNRELATED REPAIRS AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THEIR DEVICE POWERED OFF MULTIPLE TIMES WHILE ATTEMPTING TO DEFIBRILLATE. THE PATIENT, A (B)(6) OLD MALE, HAD JUST COME OUT OF CARDIAC BYPASS SURGERY AND WAS IN THE PROCESS OF BEING MOVED TO ICU WHEN HE WENT INTO CARDIAC ARREST. THE CUSTOMER POWERED THE DEVICE ON USING DC (BATTERY) POWER ONLY AND MADE TWO ATTEMPTS TO DEFIBRILLATE THE PATIENT. BOTH TIMES THAT THE CUSTOMER ATTEMPTED TO DEFIBRILLATE, WHEN THEY PRESSED THE SHOCK BUTTON AND THE DEVICE POWERED OFF BY ITSELF. THE CUSTOMER THEN OBTAINED A BACKUP DEVICE (ALSO A LIFEPAK 20) AND PLUGGED IN THE SAME QC THERAPY CABLE AND QC DEFIBRILLATION ELECTRODES AND WERE ABLE TO PROVIDE A 300 JOULE DEFIBRILLATION SHOCK TO THE PATIENT. MULTIPLE ADDITIONAL SHOCKS WERE PROVIDED USING THE BACKUP DEVICE. THERE WAS APPROXIMATELY 8 MINUTES BETWEEN THEIR FIRST ATTEMPT TO DEFIBRILLATE THE PATIENT AND WHEN THEY PROVIDED THE SUCCESSFUL SHOCK. THE CUSTOMER ALSO ADVISED THAT CPR WAS PERFORMED ON THE PATIENT THROUGHOUT THE EVENT AND THAT ACLS PROTOCOL MEDICATIONS WERE DELIVERED. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204318 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death