BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920499 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03213
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE ELECTRODE BELT FAILED A DEFIBRILLATOR TEST. THE ELECTRODE BELT DISTRIBUTION NODE PCA BOARD WAS NOT PRODUCING ANY OUTPUT DUE TO SHORTED COMPONENTS U713, U728, U727, AND ESD700. THE ROOT CAUSE FOR THE DEFECTIVE COMPONENTS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6) FEMALE PT'S ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT FAILED A DEFIBRILLATOR TEST. 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 77 YR