BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073023 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00964
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 3, 2013
    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 SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) IS CURRENTLY UNDERWAY. UPON EVALUATION, THE CHARGER WAS ALTERNATING BETWEEN CHARGING THE BATTERY AND DISPLAYING THE 'INSERT BATTERY' MESSAGE. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, CHARGER/MODEM SN (B)(4) WAS FOUND TO BE DEFECTIVE. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144359 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA