BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2190048 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00110
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 28, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVAL, THE ONE OF THE PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WAS BENT. THE CAUSE FOR THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO THE CONNECTOR BEING FORCED INTO THE MONITOR WHILE THE PINS WERE MISALIGNED. THE BELT WAS FULLY FUNCTIONAL ONCE THE TRUNK WAS REPLACED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE IS GETTING A SERVICE CODE 204 WHEN HE POWERS ON THE MONITOR. THE PT WAS PROVIDED WITH 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 62 YR