BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940539 · Received April 18, 2014

    Report

    Report Number
    3008642652-2014-01209
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS NOT BEEN COMPLETED AS THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. UPON RECEIPT, THE REPORTED PROBLEM (SERVICE CODE 204) WILL BE INVESTIGATED. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION. NO ADVERSE EVENT RESULTED FROM THE ALLEGEDLY DEFECTIVE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING A SERVICE CODE 204 - 'BELT UNUSABLE'. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238724 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR