BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3872582 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01588
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF CHARGER SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE CHARGER WAS RESETTING. THE CAUSE OF THE INABILITY TO POWER ON WAS ISOLATED TO A DEFECTIVE POWER BRICK CONNECTOR. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODE'S POWER SUPPLY.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICES, BATTERY CHARGER/MODEM SN (B)(4) WAS RESETTING. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309255 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA