BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173294 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01486
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: BELT SN (B)(4) HAS NOT YET BEEN RETURNED FOR EVAL. THE REPORTED PROBLEM (DAMAGED CABLE OR WIRES EXPOSED) HAS NOT BEEN ABLE TO BE CONFIRMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE ELECTRODE BELT AND COMPLETION OF THE DEVICE EVAL. NO ADVERSE EVENT RESULTED AS A RESULT OF THE REPORTEDLY DEFECTIVE ELECTRODE BELT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE WIRES THAT COME OUT OF THE BOTTOM OF THE VIBRATION BOX WERE COMING OUT AND THE DEVICE WAS ASKING THEM TO ADD GEL. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254187 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR