BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843871 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02865
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 25, 2012
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT RECEPTACLE WAS PARTIALLY DISCONNECTED FROM ELECTRODE BELT CONNECTOR J1001, WHICH CAUSED THE SERVICE CODE 204. THE ROOT CAUSE FOR THE PARTIALLY DISCONNECTED ELECTRODE BELT CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING A SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR