BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3060724 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00803
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 20, 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 (GEL PREVIOUSLY RELEASED/ POTENTIAL DAMAGE) HAS BEEN CONFIRMED. UPON EVALUATION, THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WAS PULLED FROM THE DN STRAIN RELIEF, DAMAGING INTERNAL WIRES. THE CAUSE OF THE FALSE 'GEL PREVIOUSLY RELEASED' FLAGS IS THE DAMAGE TO THE INTERNAL WIRES. THE CAUSE OF THE DAMAGED WIRES IS THE PULLED CABLE. THE ROOT CAUSE OF THE PULLED CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE PATIENT TO EXCHANGE HIS ELECTRODE BELT. THE PATIENT'S DOWNLOAD REVEALED MULTIPLE OCCURRENCES OF THE "GEL PREVIOUSLY RELEASED" FLAG. THERE WERE, HOWEVER, NO CORRESPONDING GEL RELEASE EVENTS, INDICATING POTENTIAL DAMAGE TO THE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130570 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR