BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3172797 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01458
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 28, 2013
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION, THE Q1 TRANSISTORS IN ECG A AND ECG B WERE FOUND TO BE OUT OF TOLERANCE, RESULTING IN ADJUST BELT ALARMS. THE ROOT CAUSE FOR THE DEFECTIVE TRANSISTORS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE Q1 TRANSISTORS. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING FREQUENT ADJUST BELT ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241482 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR