BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3040413 · Received March 12, 2013

    Report

    Report Number
    3008642652-2013-00699
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ZOLL LIFECORE CORP
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE ELECTRODE BELT FAILED A BI-PHASIC PULSE TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO SHORTED U727 AND U728 MICROPROCESSORS ON THE DISTRIBUTION NODE PCA BOARD. THE ROOT CAUSE FOR THE SHORTED COMPONENTS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED COMPONENTS. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6 )MALE PT'S ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT FAILED A BI-PHASIC PULSE TEST. THE PT WAS USED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104347 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECORE CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR