BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112162 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01047
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    November 21, 2013
    Report Date
    April 11, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED THE FALL-OFF TEST. THE WHITE DRIVEN GROUND WIRE WAS OPEN IN THE TRUNK CABLE INSULATION. THE CAUSE FOR THE ALARMS WAS THE OPEN WIRE. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE ON THE ELECTRODE BELT TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT AN UNKNOWN (B)(6) PATIENT WAS RECEIVING CHECK ELECTRODE BELT ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193541 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK