BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3944169 · Received May 7, 2014

    Report

    Report Number
    3008642652-2014-01391
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADD GEL/REPLACE BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION, THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM STRAIN RELIEF. THE CAUSE FOR THE ALARMS WAS THE DAMAGED CABLES. THE ROOT CAUSE OF THE DAMAGED CABLES COULD NOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ADD GEL/REPLACE BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274938 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR