BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5123991 · Received October 2, 2015

    Report

    Report Number
    3008642652-2015-05914
    Event Type
    Death
    Date Received
    October 2, 2015
    Date of Event
    September 1, 2015
    Report Date
    October 1, 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

    DEVICE EVALUATION SUMMARY: MONITOR (B)(4) AND BELT (B)(4) WERE INVOLVED IN THE EVENT ON (B)(6) 2015. THE PATIENT'S EQUIPMENT WAS REPLACED AFTER THE EVENT. MONITOR (B)(4) AND BELT (B)(4) WERE INVOLVED IN THE EVENT ON (B)(6) 2015. BELT (B)(4) HAS NOT BEEN RECOVERED FROM THE FIELD. MONITOR WAS RETURNED AND EVALUATED AT ZOLL MANUFACTURING CORPORATION. BELT (B)(4) WAS RETURNED TO THE DISTRIBUTOR AND SCRAPPED DUE TO A POTENTIAL BIOHAZARD. MONITOR (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. DEVICE EVALUATIONS INCLUDED A REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENTS 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 ALARMS, 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. DEVICE MANUFACTURE DATE & USAGE OF DEVICE MONITOR (B)(4): 05/30/2013; ELECTRODE BELT (B)(4): 07/01/2014. MONITOR (B)(4): (B)(6) 2013; ELECTRODE BELT (B)(4): (B)(6) 2014.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN THE HOSPITAL, CONNECTED TO TELEMETRY, WHILE WEARING THE LIFEVEST. CPR EFFORTS WERE PERFORMED BY THE NURSING STAFF. THE PATIENT ALSO WAS REPORTED TO HAVE RECEIVED ONE TREATMENT SHOCK THE DAY PRIOR, ON (B)(6) 2015 AND TWO TREATMENT SHOCKS ON (B)(6) 2015. RAPID ATRIAL FIBRILLATION CONTRIBUTED TO THE FIRST FALSE DETECTION AND CPR ARTIFACT CONTRIBUTED TO THE SECOND AND THIRD DETECTIONS. THE UNDERLYING RHYTHM AT THE TIME IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT WAS CONSCIOUS DURING THE FIRST SHOCK EVENT, BUT WAS REPORTEDLY UNCONSCIOUS DURING THE SECOND AND THIRD SHOCKS. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENTS. THE PATIENT PASSED AWAY (B)(6) 2015. THE PATIENT'S NURSE ALSO REPORTED BEING SHOCKED DURING THE EVENTS ON (B)(6) 2015 WHILE PERFORMING CPR. SHE DID NOT REQUIRE MEDICAL ATTENTION. THE LIFEVEST PROVIDES ALARMS FOR BYSTANDERS TO STAND BACK DURING TREATMENT SEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652255 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death