BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250081 · Received November 7, 2014

    Report

    Report Number
    3008642652-2014-03676
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    September 30, 2014
    Report Date
    November 4, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) IS COMPLETE. THE MONITOR WAS FULLY FUNCTIONAL UPON RECEIPT. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. UPON RECEIPT, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING ECG 'C' AND 'D' WAS PULLED OUT OF THE STRAIN RELIEF. THE CAUSE OF THE TEST FAILURE WAS THE PULLED ECG CABLE. THE ROOT CAUSE OF THE PULLED DCABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE, PERHAPS REMOVAL OF THE LIFEVEST FROM EMS. REVIEW OF THE PT'S ECG STRIPS AND FLAG FILES DOES NOT INDICATE A DEVICE MALFUNCTION DURING USE. THERE IS NO REASON TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    A UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2014. A REVIEW OF THE LIFEVEST'S RECORDING REVEALED THE PT'S HEART RHYTHM DETERIORATED FROM A SINUS BRADYCARDIA AT 32 BPM TO ASYSTOLE AT 23:52:04 ON (B)(6) 2014. BRADYCARDIA AND ASYSTOLE ARE CONSIDERED NON-SHOCKABLE RHYTHMS. THE LIFEVEST PROPERLY ALARMED FOR BYSTANDERS TO CALL FOR HELP AND BEGIN CPR. THE PT WAS AT HOME AT THE TIME OF DEATH. PRIOR TO PASSING, THE PT RECEIVED TREATMENT SHOCK AT 00:22:46 IN RESPONSE TO ASYSTOLE. OVER-SENSING OF SMALL CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTION. THE PT'S NEIGHBORS HEARD THE DEVICE ALARMING AND CALLED 911. THE RESPONSE BUTTONS WERE PRESSED BRIEFLY BEFORE THE ELECTRODE BELT WAS DISCONNECTED AT 01:06:09.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719344 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death