BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2031504 · Received March 21, 2011

    Report

    Report Number
    3002158293-2011-00337
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 17, 2011
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONNECTOR LOOSE) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS BROKEN, AND SEVERAL WIRES WERE CUT. THE CAUSE FOR THE DAMAGED CONNECTOR AND CUT WIRES CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WAS SAYING CONNECT BELT AND THAT THE CONNECTOR WAS LOOSE. THE PATIENT RESEATED THE BELT AND MONITOR CONNECTION, BUT THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 70 YR