BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2240953 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00414
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 9, 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 (UNABLE TO BASELINE) HAS BEEN CONFIRMED. UPON EVALUATION, THE BLUE AND RED WIRE BETWEEN ECGS C AND D WAS SHORTED, CAUSING THE ELECTRODE BELT'S +5 POWER SUPPLY TO SHORT. THE CAUSE FOR THE SHORTED WIRE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE ELECTRICAL SHORT. THE PATIENT RECEIVE A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING A (B)(6) MALE PATIENT TO REPORT THAT SHE WAS UNABLE TO BASELINE THE EQUIPMENT. THE PATIENT WAS PROVIDED WITH A NEW ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR