BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4093055 · Received September 10, 2014

    Report

    Report Number
    3008642652-2014-02797
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 8, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (WILL NOT POWER A MONITOR) WAS CONFIRMED. AS RECEIVED, THE BATTERY PACK WOULD NOT POWER A MONITOR. UPON EVAL, THE PCA BOARD AND CELLS WERE DAMAGED. THE CAUSE OF THE BATTERY PACK'S INABILITY TO POWER ON A MONITOR IS THE DAMAGED PCA AND CELLS. THE CAUSE OF THE DAMAGED PCA AND CELLS WAS ISOLATED TO LIQUID CONTAMINATION. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559847 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA