BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844834 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02915
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 1, 2012
    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 BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (INTERMITTENTLY POWERS DOWN) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CONNECTOR ON THE BATTERY CHARGER'S POWER SUPPLY BRICK WAS DEFECTIVE, CAUSING THE INTERMITTENT POWER DOWNS. THE ROOT CAUSE FO R THE DEFECTIVE POWER SUPPLY BRICK CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PATIENT'S BATTERY CHARGER WAS INTERMITTENTLY POWERING DOWN. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    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 61 YR