BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1965248 · Received December 23, 2010

    Report

    Report Number
    3002158293-2010-01350
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 16, 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 (BELT UNABLE TO CONNECT WITH THE MONITOR) HAS BEEN CONFIRMED. UPON INSPECTION, THE ELECTRODE BELT WAS FOUND TO HAVE THE CONNECTOR PINS BENT IN A SWIRL PATTERN. THE ELECTRODE BELT CONNECTOR PINS DID NOT SUCCESSFULLY MATE WITH THE CONNECTOR. THE ROOT CAUSE OF THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO THE CONNECTOR BEING FORCED INTO THE MONITOR WHILE THE PINS WERE MISALIGNED. NO ADVERSE EVENT RESULTED FROM THE BENT CONNECTOR PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) OLD MALE PATIENT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THEY WERE ATTEMPTING TO PUT THE DEVICE BACK ON THE PATIENT AND THE BELT AND MONITOR WERE UNABLE TO CONNECT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR