BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3072318 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00908
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 2, 2013
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WRENCH CODE 6) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE FRONT RESPONSE BUTTON WAS STUCK, WHICH CAUSED THE WRENCH CODE REPORTED BY THE PT. THE ROOT CAUSE OF THE STUCK RESPONSE BUTTON WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WAS DISPLAYING A WRENCH CODE 6 (RESPONSE BUTTON STUCK). THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141864 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR