BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1900087 · Received November 11, 2010

    Report

    Report Number
    3002158293-2010-01179
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON EVAL, THE CHARGER WAS FOUND TO HAVE A DEFECTIVE INTERNAL COMPONENT (U13). COMPONENT U13 IS AN 8-BIT CMOS FLASH MICRO-CONTROLLER LOCATED ON THE CHARGER PCA BOARD. THE ROOT CAUSE OF THE DEFECTIVE U13 CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) OLD FEMALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER BATTERY CHARGER CONTINUED TO REBOOT. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    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 49 YR