BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3150269 · Received May 29, 2013

    Report

    Report Number
    3008642652-2013-01394
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 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 (CHECK THERAPY PAD MESSAGES, SERVICE CODE 204) WAS CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. IN ADDITION THERE WAS CORROSION ON MULTIPLE COMPONENTS OF THE ELECTRODE BELT. THE J702, J703 AND J704 CONNECTORS, THE DN PCA, THE TRUNK CABLE CONNECTOR, THE DN TO FRONT TE CABLE AND ECG C AND D CABLE HAD CORROSION DAMAGE. THE ROOT CAUSE OF THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. THE ROOT CAUSE FOR THE CORROSION WAS UNABLE TO BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF CONTAMINATION. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CHECK THERAPY PAD MESSAGES AND A SERVICE CODE 204 (BELT/MONITOR UNUSABLE). THE PATIENT WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233684 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR