BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2140312 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00062
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 15, 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 107) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT. NO PROBLEMS WERE FOUND WITH THE PATIENT'S MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT SERVICE CODE 107 APPEARED ON HIS MONITOR. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT AND MONITOR.

    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 75 YR