BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3210053 · Received June 27, 2013

    Report

    Report Number
    3008642652-2013-01703
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES AND CAUSING THE REPORTED "ADD GEL" MESSAGES. THE ROOT CAUSE FOR THE STRAINED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U13 COMPONENT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM A (B)(6) MALE PT REVEALED THAT THE PT WAS RECEIVING "ADD GEL" MESSAGES. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293051 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR