BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2251372 · Received August 12, 2011

    Report

    Report Number
    3008642652-2011-00442
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 26, 2011
    Report Date
    August 11, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (LEAKING GEL) HAS BEEN CONFIRMED. UPON EVAL, THERE WAS A FALLOFF FAILURE ON THE ECGS. THE ROOT CAUSE OF THE FALLOFF FAILURE WAS ISOLATED TO THE PCA BOARD IN THE DISTRIBUTION NODE. THE FALLOFF FAILURE INDICATES EXCESSIVE NOISE ON THE CHANNELS WHEN THE ECGS ARE NOT MAKING GOOD CONTACT WITH THE PT'S SKIN. CONVERSELY, WHEN THE ELECTRODES ARE TOUCHING THE SKIN, AN ECG SIGNAL WILL NOT BE RECORDED, AS ELECTRODE FALLOFF IS SEEN. NO ADVERSE EVENT RESULTED FROM THE FALLOFF FAILURE. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE FRONT THERAPY PAD IS SLOWLY LEAKING GEL. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR