BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2240949 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00413
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 9, 2011
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THE J702 CONNECTOR ON THE DISTRIBUTION NODE (DN) PCA BOARD WAS BENT WHICH HALTED COMMUNICATION BETWEEN THE DN AND THE MONITOR. THE ROOT CAUSE OF THE BENT J702 CONNECTOR WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BENT J702 CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS GETTING A MESSAGE THAT "THE DEVICE WAS NOT WORKING" (SERVICE CODE 204). THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 38 YR