BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2010324 · Received February 11, 2011

    Report

    Report Number
    3002158293-2011-00156
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 23, 2010
    Report Date
    February 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT BASELINE PT) HAS BEEN CONFIRMED. UPON EVAL, BOTH CHANNELS (SIDE-SIDE AND FRONT-BACK) WERE NOISY WHEN THE ELECTRODE BELT CABLE (BETWEEN ECG B TO THE DISTRIBUTION NODE) WAS MANIPULATED. THE CAUSE FOR THE CHANNEL NOISE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF DAMAGED INTERNAL WIRING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PT TO REPORT THAT SHE WAS UNABLE TO BASELINE THE PT. THE PSR WAS UNABLE TO TROUBLESHOOT THE ISSUE. THE PT WAS ISSUED A REPLACEMENT 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 58 YR