BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823433 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01202
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 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 CHARGE/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE BATTERY BOARD WAS CONTAMINATED. THE CAUSE OF THE RESETS IS THE CONTAMINATED BATTERY BOARD. THE ROOT CAUSE OF THE CONTAMINATED BATTERY BOARD COULD NOT BE POSITIVELY IDENTIFIED BUT IS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY BOARD IN THE 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 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
    262174 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA