BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6465346 · Received April 6, 2017

    Report

    Report Number
    3008642652-2017-02885
    Event Type
    Death
    Date Received
    April 6, 2017
    Date of Event
    February 22, 2017
    Report Date
    April 6, 2017
    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: THE ELECTRODE BELT SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES 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. THE DISTRIBUTOR FUNCTIONALITY TESTING CONFIRMED THAT THE DEVICE WAS FULLY FUNCTIONAL. THE ELECTRODE BELT PULSE DELIVERY AND ECG ACQUISITION CIRCUITRY WAS FULLY FUNCTIONAL. THE MONITOR SN (B)(4) WAS RETURNED TO ZOLL MANUFACTURING CORPORATION FOR EVALUATION. THE EVALUATION IS CURRENTLY UNDERWAY. A REVIEW OF THE DOWNLOADED SOFTWARE FLAG ON THE DAY OF THE EVENT WAS COMPLETED. 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. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 05/03/2012 REUSE; ELECTRODE BELT: SN (B)(4): 12/18/2015 REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED BY THE LIFEVEST AND PASSED AWAY ON (B)(6) 2017. THE LIFEVEST DETECTED AN ARRHYTHMIA AT 05:35:29 ON (B)(6) 2017. THE LIFEVEST DEPLOYED GEL AND DELIVERED A TREATMENT AT 05:36:13. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS VENTRICULAR FIBRILLATION (VF). THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. FROM THE DOWNLOADED ECG RECORDINGS, THE PATIENT REMAINED IN ASYSTOLE OR BRADYCARDIA FOLLOWING THE TREATMENT. ASYSTOLE AND BRADYCARDIA ARE CONSIDERED NON-TREATABLE RHYTHMS. CPR ARTIFACTS PRESENT ON THE ECG RECORDINGS INDICATES THE PRESENCE OF BYSTANDERS. THE DEVICE WAS SHUTDOWN AT 07:01:52 ON (B)(6) 2017. THE TIME OF THE PATIENT'S DEATH IS UNKNOWN. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIAL OUTCOME OF DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247329 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O