BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4252887 · Received September 4, 2014

    Report

    Report Number
    3008642652-2014-02692
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED PROBLEM (RESETTING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING AND UNABLE TO RECOGNIZE A BATTERY PACK. THE CAUSE FOR THE RESETS WAS ISOLATED TO A THERMALLY DAMAGED U13 CMOS FLASH MICROCONTROLLER ON THE BESIDE PCA. ADDITIONALLY, CONTAMINATION WAS FOUND WITHIN THE CHARGER. THE ROOT CAUSE FOR THE DAMAGED U13 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) TO REPORT THAT THE BATTERY CHARGER/MODEM WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539994 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA