BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1935175 · Received December 7, 2010

    Report

    Report Number
    3002158293-2010-01265
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 28, 2010
    Report Date
    December 4, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. UPON RECEIPT, THE TRUNK CABLE CONNECTOR WAS BROKEN. THE ROOT CAUSE OF THE BROKEN TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THERE IS A MESSAGE ON THE MONITOR STATING "DEVICE NEEDS TO BE SERVICED" ALONG WITH A PICTURE TO CONNECT THE BELT TO THE MONITOR. THE PT'S ELECTRODE BELT WAS REPLACED.

    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 50 YR