BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983757 · Received June 25, 2014

    Report

    Report Number
    3008642652-2014-01935
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN INTERMITTENT GREEN (#3.3V) WIRE IN THE TRUNK CABLE CONNECTOR. THE OPEN WIRE CAUSED THE MONITOR COMMUNICATION ISSUES, WHICH LIKELY RESULTED IN ABNORMAL SHUTDOWNS. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE TRUNK CABLE CONNECTOR. NO ADVERSE EVENT RESULTED FROM THE ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE DOWNLOAD DATA FOR A (B)(6) MALE PT REVEALED SEVERAL INSTANCES OF CODE 107 (MULTIPLE ABNORMAL SHUTDOWNS). ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371581 LIFEVEST WCD 4000 SYSTEM WEARABEL CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR