BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080854 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00962
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 4, 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 REPORTER PROBLEM (CHECK THERAPY ELECTRODE AND CHECK ELECTRODE BELT ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE WHITE PULSE WIRE WAS OPEN IN THE TRUNK CABLE INSULATION AND THE PULSE WIRE IN THE CABLE THAT CONNECTS THE DISTRIBUTION NODE (DN) TO FRONT THERAPY ELECTRODE WAS ALSO OPEN. THE OPEN PULSE WIRES CAUSED BY THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN PULSE WIRES COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE ON THE ELECTRODE BELT CABLE SECTIONS. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PATIENT WAS RECEIVING CHECK THERAPY ELECTRODE AND CHECK ELECTRODE BELT ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158614 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR