BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3170426 · Received May 24, 2013

    Report

    Report Number
    3008642652-2013-01423
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ZOLL LIFECOR 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: BELT SN (B)(4) HAS NOT YET BEEN RETURNED FOR EVALUATION. THE REPORTED PROBLEM (CODE 204 - BELT/MONITOR UNUSABLE) HAS NOT BEEN ABLE TO BE CONFIRMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE ELECTRODE BELT AND COMPLETION OF THE DEVICE EVALUATION. NO ADVERSE EVENT RESULTED AS A RESULT OF THE REPORTEDLY DEFECTIVE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT HAD A MESSAGE ON HIS MONITOR THAT "THE DEVICE HAS A PROBLEM." THE PATIENT THEN REPORTED THAT HIS MONITOR WAS DISPLAYING CODE 204 - BELT/MONITOR UNUSABLE. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230899 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR