BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 4080963 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02124
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (ADJUST BELT/CHECK BELT MESSAGES AND ARRHYTHMIA ALARMS) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED THE DETECT AND TREAT TEST. UPON EVAL, U1 WAS SHORTED. THE CAUSE OF THE TEST FAILURE WAS THE SHORTED U1. THE SHORTED U1 WAS CAUSED BY A PIECE OF SOLDER LODGED BETWEEN PIN 1 AND PIN 2 IN ECG 'C'. THE ROOT CAUSE OF THE LODGED SOLDER CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS ELECTRODE BELT WAS GIVING HIM ADJUST BELT/CHECK BELT MESSAGES AND ARRHYTHMIA ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400889 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR