BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1972679 · Received January 20, 2011

    Report

    Report Number
    3002158293-2011-00073
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 18, 2011
    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 EVAL SUMMARY: EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED RESPONSE BUTTONS) HAS BEEN CONFIRMED. THE CAUSE OF THE NONFUNCTIONAL FRONT RESPONSE BUTTON WAS PHYSICAL DAMAGE TO THE SWITCH. THE METALLIC DOMES HAD BEEN PEELED OFF THE FRONT SWITCH. THE SOURCE OF THE PHYSICAL DAMAGE CANNOT BE POSITIVELY IDENTIFIED. ONCE THE RESPONSE BUTTON WAS REPLACED, THE MONITOR WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE FRONT RESPONSE BUTTON CAME OFF OF THE MONITOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    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 75 YR