BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4321223 · Received December 2, 2014

    Report

    Report Number
    3008642652-2014-04612
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 4, 2014
    Report Date
    December 1, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 OF BATTERY SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (BATTERY WON'T POWER MONITOR) WAS CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGER OR POWER ON A MONITOR. UPON EVALUATION THE BATTERY CELL VOLTAGES WERE MIS-MATCHED AT 4.238V, -1.89SV, AND 4.241V. THE CAUSE FOR THE INABILITY TO CHARGE IN A CHARGER OR POWER ON A MONITOR IS THE MIS-MATCHED CELLS. THE ROOT CAUSE OF THE MIS-MATCHED CELLS WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT BATTERY SN (B)(4) WOULD NOT POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777043 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA