BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941558 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01172
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 14, 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 SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE CHARGER WAS RESETTING. THE CAUSE OF THE RESETS WAS ISOLATED TO CORRUPT PROGRAMMING ON THE CHARGERS CA BOARD. THE ROOT CAUSE OF THE CORRUPT PROGRAMMING WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE LAST PATIENT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235953 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA