BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4161442 · Received July 23, 2014

    Report

    Report Number
    3008642652-2014-02307
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 22, 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 PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER ON A MONITOR) WAS CONFIRMED. UPON EVALUATION, THE BATTERY WAS NON-FUNCTIONAL IN A BATTERY AND A CHARGER. THE OUTPUT VOLTAGE WAS 2.08 VOLTS. THE CAUSE OF THE INABILITY TO POWER ON A MONITOR AND CHARGER IS THE LOW OUTPUT VOLTAGE. THE ROOT CAUSE OF THE LOW OUTPUT VOLTAGE IS UNABLE TO BE POSITIVELY IDENTIFIED, BUT IS LIKELY DEFECTIVE CELLS. NO ADVERSE EVENT RESULTED FROM DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A BATTERY PACK WAS UNABLE TO POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430725 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA