BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM

    MDR report key: 840857 · Received April 13, 2007

    Report

    Report Number
    3002807968-2007-00004
    Event Type
    Injury
    Date Received
    April 13, 2007
    Date of Event
    March 30, 2007
    Report Date
    April 12, 2007
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    KLK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE DEVICE HAS FAILED. ACCORDING TO THE OPERATOR'S MANUAL, THE SITE FOR THE ELECTRODES MUST BE CHANGED AT LEAST EVERY FOURTH HOUR. SITE TIME ALARM FOR CHANGE OF ELECTRODE SITE HAS BEEN GIVEN AFTER 4 HOURS, BUT THE CUSTOMER HAS IGNORED THE ALARMS. THEY HAVE LEFT THE ELECTRODES IN THE SITE FOR AN EXTRA 30 MINUTES AFTER THE ALARM HAD BEEN ISSUED. THIS HAS BEEN DONE IN SPITE OF THE FOLLOWING WARNINGS IN THE OPERATOR'S MANUAL: 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 HOURS. 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 PTS. IF SKIN INTEGRITY CHANGES, MOVE THE ELECTRODE/SENSOR TO ANOTHER SITE. WE HAVE TRIED TO OBTAIN MORE SPECIFIC INFO ABOUT THE BURN FROM THE CUSTOMER, UNTIL NOW TO NO AVAIL. FROM THE AVAILABLE INFO, IT IS STILL NOT CLEAR WHETHER THE DEGREE OF THE BURN CONSTITUTES A SECOND DEGREE BURN, BUT WE HAVE TO CONSIDER THIS A POSSIBILITY. OUR DISTRIBUTOR HAS VISITED THE CUSTOMER AND RE-TRAINING HAS BEEN PLANNED.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT THREE BABIES HAD BEEN BURNED BY THE TRANSCUTANEOUS ELECTRODES USED WHEN MEASURING PCO2 VALUES (ALLEGEDLY A RED RING THAT DID NOT DISAPPEAR AND POSSIBLE SOME PEELING OF SKIN).

    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 YR Disability