BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1160746 · Received September 8, 2008

    Report

    Report Number
    3002158293-2008-00430
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE A SHORT CIRCUIT IN ECG A. THE SHORT WAS FIXED. THE ELECTRODE BELT WAS REFURBISHED. BASELINE EVALUATION WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS SHORT CIRCUIT IS UNK, BUT IS LIKELY DUE TO STRAIN PLACED ON THE CABLE. THE ELECTRODE BELT SHORT CIRCUIT WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE LIFECOR PT SERVICES REP (PSR) OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE COULD NOT BASELINE THE PT DURING THE INITIAL FITTING. SHE STATED THAT SHE COULD SEE THAT THE ECG WAS ALL ARTIFACT. A LIFECOR TERRITORY MANAGER REBASELINED THE PT 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 48 YR