BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2904560 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03166
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD. THE CAUSE OF THE INABILITY TO POWER ON IS THE CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(4) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WOULD NOT POWER ON. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR