BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2082148 · Received April 28, 2011

    Report

    Report Number
    3002158293-2011-00473
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: MONITOR (B)(4) WAS FORWARDED TO ZOLL ENGINEERING UPON RECEIPT FOR FAILURE ANALYSIS. UPON RECEIPT, THE DEVICE WOULD NOT POWER ON. PRELIMINARY ANALYSIS INDICATES THE 5 VOLT POWER SUPPLY FAILED, WHICH CAUSED THE CONVERTER TO STAY POWERED ON. THIS, IN TURN, CAUSED A CAPACITOR ON THE HIGH VOLTAGE BOARD (C19) TO OVERHEAT AND DISTORT THE SURROUNDING PLASTIC ENCLOSURE. THE CAUSE OF THE PT REPORTING A "STINGING FEELING" ON HER BACK WAS THE TACTILE MOTOR CONTINUOUSLY RUNNING WHILE THE MONITOR WAS RESETTING. ROOT CAUSE ANALYSIS OF THE FAULTY 5 VOLT SUPPLY IS STILL ONGOING. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETED ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A NURSE PRACTITIONER FROM CHILDREN'S HOSPITAL IN (B)(6) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PATIENT TO REPORT THAT THE PATIENT BELIEVES SHE WAS TREATED. HER MONITOR WILL NOT POWER ON AND THE PLASTIC CASING APPEARS TO BE MELTED. 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 16 YR