BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3983262 · Received June 27, 2014

    Report

    Report Number
    3008642652-2014-01993
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (WIRES FROM BACK TE PAD NO LONGER CONNECTED) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE DISTRIBUTION NODE (DN) TO REAR TE CABLE WAS PULLED FROM THE STRAIN RELIEF. THE CAUSE OF THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE STRAINED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF AN (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE WIRES FROM THE BACK THERAPY (TE) PAD WERE NO LONGER CONNECTED. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376985 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR