BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 3874109 · Received May 29, 2014

    Report

    Report Number
    3002807968-2014-00017
    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
    PMA / PMN Number
    K043003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINT THE TEMP OF THE SENSOR WAS SET TO 43 DEGREES CELSIUS AND THE SENSOR WAS PLACED ON THE SAME LOCATION FOR 7 HRS. ACCORDING TO THE OPERATOR'S MANUAL (TCM4/40 OM PAGE 6-12) THE PROBE SHOULD BE RELOCATED AFTER 4 HRS AT LEAST. A ZERO CHECK ON THE SENSOR WAS PERFORMED AND IT PASSED FINE. THE TEMP WAS STABLE AT 42.9 CELSIUS SO IT WAS NOT AN ISSUE WITH THE SENSOR. ADDITIONALLY, THE FIELD SERVICE ENGINEER COMPLETED THE TCM4 COMPLETE ALIGNMENT, AND MONITOR PERFORMANCE TEST AND EVERYTHING PASSED FINE. SINCE NO ERROR WAS IDENTIFIED ON THE UNIT OR SENSOR, AND IT WAS STATED THAT THE SENSOR WAS NOT RELOCATED EVERY 4 HRS AS IT SHOULD BE THIS CASE IS SUSPECTED TO BE CAUSED BY A USER ERROR.

    Description of Event or Problem · 1

    THE PT (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
    317157 TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 MONITORING SYS LKD RADIOMETER MEDICAL APS TCM4 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other