BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM

    MDR report key: 954255 · Received November 28, 2007

    Report

    Report Number
    3002807968-2007-00015
    Event Type
    Injury
    Date Received
    November 28, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 23, 2007
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    KLK
    PMA / PMN Number
    K043003
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WARNING IN THE OPERATOR'S MANUAL SAYS: DO NOT ALLOW THE TCPO2/TCPCO2 ELECTRODE TEMPERATURE TO EXCEED 43 DEGREE C FOR NEONATES AND 44 DEGREE C FOR ADULTS IF ELECTRODES ARE ATTACHED TO SKIN FOR MORE THAN FOUR HOURS. TCPO2/TCPCO2 ELECTRODE AND REUSABLE SPO2 SENSORS MUST BE MOVED TO A NEW SITE AT LEAST EVERY FOUR HRS. BECAUSE INDIVIDUAL SKIN CONDITION AFFECTS THE ABILITY OF THE SKIN TO TOLERATE ELECTRODE/SENSOR PLACEMENT, IT MAY BE NECESSARY TO CHANGE THE ELECTRODE/SENSOR SITE MORE FREQUENTLY WITH SOME PATIENTS. IF SKIN INTEGRITY CHANGES, MOVE THE ELECTRODE/SENSOR TO ANOTHER SITE. THE COMBINATION OF TEMPERATURE SETTING AND TIME OF EXPOSURE LEADING TO THIS EVENT HAS ALREADY BEEN ADDRESSED IN THE RISK ANALYSIS FOR THE PRODUCT. MITIGATION HAS BEEN IMPLEMENTED IN FORM OF THE ABOVE MENTIONED WARNING IN THE OPERATOR'S MANUAL (SEE DETAILS ABOVE) UNDER PRELIMINARY ANALYSIS. WE HAVE SEARCHED OUR CURRENT COMPLAINT DATABASE GOING BACK TO 2004 FOR SIMILAR INCIDENTS AND ONLY FOUND ONE. THEREFORE WE CONSIDER THE WARNING IN OUR OPERATOR'S MANUAL TO BE APPROPRIATE AND THE RESULT OF OUR RISK ANALYSIS STILL TO BE VALID.

    Description of Event or Problem · 1

    WHILE MONITORED BY A TRANSCUTANEOUS MONITORING DEVICE, A STUDY PATIENT SUFFERED A BURN ON HIS CHEST. THE 2 MM BLISTER WAS TREATED WITH OINTMENT AS A "MODERATE" BURN. WE HAVE ONLY LITTLE INFO ABOUT THE EVENT AND THE BURN AS THE CUSTOMER HAS BEEN RELUCTANT TO PROVIDE ANSWERS TO SEVERAL INFO REQUESTS. IT IS THEREFORE, ASSUMED THAT THE BURN CONSTITUTES A SECOND DEGREE BURN. THE CUSTOMER HAS PROVIDED INFO THAT REVEAL THAT THEY KNOW THEY HAVE LEFT THE ELECTRODE ON THE SAME SITE FOR A LONGER PERIOD THAN DESCRIBED IN THE OPERATOR'S MANUAL. THE HOSP ADMITTED THAT THEY SHOULD HAVE MOVED THE ELECTRODES EVERY 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCM TCM4 KLK RADIOMETER MEDICAL APS TCM4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Disability