BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983517 · Received June 26, 2014

    Report

    Report Number
    3008642652-2014-01981
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 REPORTER PROBLEM (CHARGER PROBLEM) WAS CONFIRMED. UPON EVALUATION THE BATTERY CHARGER/MODEM WAS UNABLE TO FULLY POWER ON. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CORRUPT SD CARD. CAUSE OF THE CORRUPTED SD CARD WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTER CHARGER. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WOULD NOT LOCATE THE CHARGER FOR DOWNLOADING. A PATIENT SERVICE REPRESENTATIVE WAS DISPATCHED TO ASSIST THE PATIENT AND REPORTED THAT THE PATIENT'S CHARGER WOULD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373946 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR