BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1845031 · Received September 10, 2010

    Report

    Report Number
    3002158293-2010-00923
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 26, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT THE U1 COMPONENT IN ECG C WAS SHORTED, CAUSING THE 5V LINE TO BE SHORTED TO GROUND. THE ROOT CAUSE OF THE SHORTED U1 COMPONENT CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE PATIENT SERVICE REPRESENTATIVE (PSR) ASSISTING A (B)(6) OLD MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING ADJUST BELT ALARMS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR