BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4827846 · Received June 5, 2015

    Report

    Report Number
    3008642652-2015-03671
    Event Type
    Death
    Date Received
    June 5, 2015
    Date of Event
    April 20, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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

    EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FOUND TO BE FULLY FUNCTIONAL. THERE WAS NO DEVICE MALFUNCTION. THE DURATION OF VF WAS TOO SHORT FOR THE LIFEVEST TO COMPLETE THE DETECTION AND TREATMENT SEQUENCE. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PT DEATH. MONITOR SN (B)(4): 09/2014. ELECTRODE BELT SN (B)(4): 06/2014.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED ZOLL THAT A (B)(6) YEAR OLD MALE PT PASSED AWAY ON (B)(6) 2015 WHILE AT HOME. EMS WAS WITH THE PT AND ATTEMPTED RESUSCITATION. THE LIFEVEST WAS NOT ALARMING. EMS EXTERNALLY DEFIBRILLATED THE PT AT 05:55:26, 05:59:06, 06:12:32, AND 06:18:00 DURING CPR ARTIFACT AND A PACED RHYTHM. A 4TH DEFIBRILLATION FROM EMS WAS PERFORMED AT 06:34:00 DURING CPR ARTIFACT. AT 06:40:00 EMS AGAIN DEFIBRILLATED THE PT DURING CPR ARTIFACT. THE POST-SHOCK RHYTHM WAS BRADYCARDIA. BETWEEN 06:40:38 AND 06:46:22, EMS DELIVERED SIX MORE EXTERNAL DEFIBRILLATION DURING VENTRICULAR FIBRILLATION (VF). AFTER THE TREATMENTS THE PT'S RHYTHM DEGRADED TO ASYSTOLE, WHICH IS CONSIDERED A NON-TREATABLE RHYTHM. THE DURATIONS OF VF WERE TOO SHORT FOR THE LIFEVEST TO COMPLETE THE DETECTION AND TREATMENT SEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366098 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death