BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 400 SYSTEM

    MDR report key: 4181822 · Received August 4, 2014

    Report

    Report Number
    3008642652-2014-02133
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE OR WIRES EXPOSED) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A TRUNK CABLE PULLED FROM THE DISTRIBUTION NODE (DN). THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE PULLED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(4) MALE PATIENT'S MOTHER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A PULLED WIRE FROM THE PATIENT'S ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453650 LIFEVEST WCD 400 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR