BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3000066 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00210
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (POPPING SOUND / WILL NOT POWER ON) IS STILL UNDER INVESTIGATION. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR OR ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND ELECTRODE BELT. DATE OF MANUFACTURE: ELECTRODE BELT: 06/2011.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A LOUD POPPING SOUND. THE MONITOR SUBSEQUENTLY WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28655 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR