BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3002553 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00401
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 11, 2013
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO POOR SOLDER AT THE J2 CONNECTOR ON THE REAR #1 THERAPY ELECTRODE PRINTED CIRCUIT BOARD. THE ROOT CAUSE FOR THE POOR SOLDER WAS AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE POOR SOLDER AT J2. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6) MALE PATIENT'S ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67582 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR