BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2881172 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03005
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 8, 2012
    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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DIFFICULTY CONNECTING THE BELT TO MONITOR / BENT PINS) HAS BEEN CONFIRMED. UPON EVALUATION, THE PINS IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR WERE BENT IN A SWIRL PATTERN. THE CAUSE OF THE DIFFICULTY CONNECTING THE BELT TO THE MONITOR IS THE BELT PINS. THE CAUSE FOR 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 DEFECTIVE ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS HAVING DIFFICULTY CONNECTING THE ELECTRODE BELT TO THE MONITOR. THE PSR THEN REPORT THAT SHE NOTICED BENT PINS IN THE ELECTRODE BELT CONNECTOR. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR