BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 3879434 · Received May 29, 2014

    Report

    Report Number
    1523456-2014-00002
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT (A NEONATAL BOY BORN IN (B)(6) GESTATION WEEK) RECEIVED A BURN MARK ON THE RIGHT THIGH. THE TEMPERATURE WAS SET TO 43 DEGREES CELSIUS, AND THE ELECTRODE WAS PLACED ON THE SAME LOCATION FOR 7 HOURS. ACCORDING TO THE OPERATOR'S MANUAL (TCM4/40 OM PAGE 6-12) THE PROBE SHOULD BE RELOCATED AFTER 4 HOURS AT LEAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316271 TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 MONITORING SYSTEM LKD RADIOMETER MEDICAL APS TCM4 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other