BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881184 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03017
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    July 13, 2012
    Report Date
    November 9, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION CONTAMINATION WAS DISCOVERED ON THE CHARGER/MODEM'S BATTERY BOARD AND BEDSIDE BOARD. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY BOARD. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S SPOUSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT TROUBLE DOWNLOADING DATA WITH THE CHARGER/MODEM. UPON REVIEW OF THE PT'S FLAG FILES A BATTERY CHARGER FAULT WAS DETECTED. THE PT WAS ISSUED A REPLACEMENT BATTERY 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 58 YR