BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2881122 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03028
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION, THE MONITOR WAS UNABLE TO BOOT UP DUE TO CORRUPT MONITOR SOFTWARE. THE ROOT CAUSE OF THE SOFTWARE CORRUPTION COULD NOT BE POSITIVELY IDENTIFIED. AFTER REPROGRAMMING THE SOFTWARE, THE MONITOR WAS FULLY FUNCTIONAL. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE CORRUPT SOFTWARE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WAS NOT POWERING UP. 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 70 YR