BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2072930 · Received April 1, 2011

    Report

    Report Number
    3002158293-2011-00367
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 26, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT PINS) HAS BEEN CONFIRMED. UPON EVAL, PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT IN A SWIRL PATTERN. 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. DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE) HAS BEEN CONFIRMED. UPON EVAL, THE FRONT-BACK AND SIDE-SIDE CHANNELS WERE NOISY WHEN THE TRUNK CABLE WAS MANIPULATED. THE ROOT CAUSE OF THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE.

    Description of Event or Problem · 1

    THE (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT SN (B)(4) HAS BENT PINS IN THE CONNECTOR AND ELECTRODE BELT SN (B)(4) HAS A DAMAGED CABLE.

    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 UNK