BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2011933 · Received February 14, 2011

    Report

    Report Number
    3002158293-2011-00177
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 11, 2011
    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 (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WON'T POWER UP - PULSE CURRENT FAULTS) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT AFTER SPEAKING WITH THE WIFE OF A (B)(6) MALE PATIENT. THE PATIENT WAS EXPERIENCING TROUBLE WITH THE LIFEVEST. THE PATIENT'S WIFE CLAIMED THE MONITOR MADE A POPPING NOISE AND THE BELT GELLED WITHOUT WARNING. A REVIEW OF THE PATIENT'S DOWNLOAD REVEALED PULSE CURRENT FAULTS AND CAN COMM TIMEOUTS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR