BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5123992 · Received October 2, 2015

    Report

    Report Number
    3008642652-2015-06104
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION CONTRIBUTING TO THE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: BELT SN (B)(4) WAS RETURNED TO THE DISTRIBUTOR AND SCRAPPED DUE TO A POTENTIAL BIOHAZARD. MONITOR SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES (ATTACHED) ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE DEVICE, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE AUDIO MESSAGING AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. A REVIEW OF THE PATIENT'S DOWNLOADED FLAG FILE CONFIRMED THAT THE DEVICE DECLARED A TREATABLE ARRHYTHMIA AND SUBSEQUENTLY DELIVERED FIVE TREATMENT SHOCKS. THE ASSOCIATED ECG STRIPS OF THE TREATMENT EVENT COULD NOT BE RECOVERED DUE TO AN SD CARD FAULT. AS SUCH, THE EXACT RHYTHM AT THE TIME OF THE EVENT CANNOT BE CONFIRMED. SINCE IT CANNOT DEFINITIVELY CONFIRM THAT THE TREATMENT WAS APPROPRIATE, THE EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE SD CARD FAULT DID NOT PRECLUDE THE DEVICE'S ABILITY TO DETECT AN ARRHYTHMIA AND DELIVER A TREATMENT DEFIBRILLATION. ROOT CAUSE INVESTIGATION INTO THE SD CARD FAULT IS UNDERWAY. DEVICE MANUFACTURE DATE: MONITOR: 08/14/2014. BELT: 07/17/2014.

    Description of Event or Problem · 1

    US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED. THE PATIENT WAS REPORTEDLY WALKING UP THE STAIRS WHEN SHE HEARD THE SIREN ALARMS. SHE REPORTEDLY PRESSED THE RESPONSE BUTTONS BEFORE RECEIVING A SHOCK. THE PATIENT CALLED THE AMBULANCE AND REPORTEDLY WAS SHOCKED AN ADDITIONAL TIME IN THE AMBULANCE. REVIEW OF THE EVENT CONFIRMS THAT THE RESPONSE BUTTONS WERE PRESSED APPROXIMATELY ONE MINUTE PRIOR TO SHOCK DELIVERY. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE PATIENT WENT TO THE HOSPITAL AND CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654505 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O