BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3974874 · Received June 11, 2014

    Report

    Report Number
    3008642652-2014-01766
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ZOLL LIFE 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 SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO POWER UP. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE POWER SUPPLY BRICK. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE LAST PT TO SUE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER UP. THE LAST PATIENT TO USE THE BATTERY CHARGER/MODEL DID NOT REPORT ANY DEFICIENCIES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343838 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLAOTR MVK ZOLL LIFE CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA