BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823438 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01208
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 17, 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 SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CHARGER/ MODEM WAS RESETTING. UPON EVALUATION, THERE WAS CORRUPTED SOFTWARE ON THE FLASH MEMORY. THE CAUSE OF THE RESETS IS THE CORRUPTED SOFTWARE THE ROOT CAUSE OF THE CORRUPTED SOFTWARE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED SOFTWARE THE LAST PATIENT TO USE THIS CHARTER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATE DETECTED A REPORTABLE PROBLEM. DURING SERVICING, CHARGER/MODEM SN (B)(4) WAS RESETTING. THE LAST PATIENT TO USE THIS CHARGER/ MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261947 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA