BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1942918 · Received December 23, 2010

    Report

    Report Number
    3002158293-2010-01330
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 13, 2010
    Report Date
    December 13, 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 (BENT PINS IN CONNECTOR) 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

    A PSR ASSISTING A (B)(6) FEMALE PATIENT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THERE WERE BENT PINS IN THE PATIENT'S ELECTRODE BELT CONNECTOR, CAUSING THE MONITOR NOT TO RECOGNIZE THE BELT CONNECTION. 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 WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR