BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3973088 · Received June 5, 2014

    Report

    Report Number
    3008642652-2014-01707
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULT/CHARGER FAULT) WAS CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD. THE CAUSE OF THE BATTERY FAULT/CHARGER FAULT IS THE CONTAMINATED BATTERY BOARD. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACT ZOLL CUSTOMER SUPPORT TO REPORT BATTERY FAULTS/CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328413 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR