BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 3950972 · Received July 14, 2014

    Report

    Report Number
    3002807968-2014-00021
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 13, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LPP
    PMA / PMN Number
    K001866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TCM400 HAS BEEN CHECKED, AND NO INDICATIONS OF PRODUCT MALFUNCTION WERE IDENTIFIED. IT IS STATED IN THE INTENDED USE THAT THE TCM400 SYSTEM SHOULD NOT BE USED IN ICU AND FOR UNATTENDED PATIENT MONITORING, AS THE SYSTEM HAS NO ALARMS. ALSO THE FOLLOWING WARNINGS ARE INCLUDED: IN THIS CASE THE PATIENT WAS SUFFERING FROM CRITICAL LIMB ISCHEMIA. THIS CONDITION RESULTS IN REDUCED BLOOD FLOW TO THE FEET, AND THE PLACEMENT OF THE ELECTRODE IN THE SAME POSITION FOR TWO HOURS IS THEREFORE SUSPECTED TO HAVE CAUSED THE BURN MARK.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SECOND DEGREE BURN MARK ON THE TOP OF HIS RIGHT FOOT, AFTER THE TCM400 SENSOR WAS REMOVED. THE TEMPERATURE WAS SET TO 44 DEGREES CELSIUS, AND THE ELECTRODE WAS PLACED ON THE SAME LOCATION FOR 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410098 TRANSCUTANEOUS BLOOD GAS MONITOR TCM400 LPP RADIOMETER MEDICAL APS TCM400 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other