BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2052471 · Received March 16, 2011

    Report

    Report Number
    3002158293-2011-00307
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 14, 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 (CHECK TE MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE PULSE WIRES BETWEEN ECGS A AND B WERE INTERMITTENT. THERE WERE NO VISUAL DEFECTS, AND NO CUT WIRES. THE ROOT CAUSE FOR THE INTERMITTENT CONNECTION CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE OPEN CONNECTION. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE IS RECEIVING CONSTANT CHECK THERAPY ELECTRODE PAD MESSAGES. 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 59 YR