BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890840 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03100
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 21, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WIRES SHOWING ON MONITOR WHERE BELT IS CONNECTED) HAS BEEN CONFIRMED. UPON EVAL, THE BELT RECEPTACLE WAS BROKEN FROM THE MONITOR CASE, WHICH CAUSED J1001 (TRUNK CABLE CONNECTOR) TO PARTIALLY DETACH. THE ROOT CAUSE FOR THE DAMAGED BELT RECEPTACLE AND CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE AT THE BELT CONNECTOR WHILE THE ELECTRODE BELT WAS ATTACHED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT WIRES WERE SHOWING ON THE MONITOR WHERE THE ELECTRODE BELT CONNECTS. 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 64 YR