BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC MONITOR

    MDR report key: 661907 · Received September 15, 2005

    Report

    Report Number
    3002807968-2004-00020
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Report Date
    December 10, 2004
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    KLK
    Removal / Correction Number
    3002807-12/10/2004-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USING A CERTAIN SEQUENCE OF COMMANDS THE INSTRUMENT COULD REPORT A WRONG PATIENT ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC MONITOR TRANCUTANEOUS OXYGEN AND CARBONDIOXIDE MONIT KLK RADIOMETER MEDICAL APS TCM 4 *

    Patients

    Seq Age Sex Outcome Treatment
    1