BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 4255671 · Received November 7, 2014

    Report

    Report Number
    3002807968-2014-00055
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K043003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH UNITS HAVE BEEN RECEIVED AND TESTED BY RADIOMETER. THE UNITS NEEDED NEW BATTERIES BUT APART FROM THIS ALL TESTS WERE PASSED. THE SENSOR TEMPERATURE WAS SET TO 43 DEGREES ON BOTH UNITS AND THE SITE TIME WAS SET TO 10 HRS ON ONE UNIT (B)(4) AND 4 HRS ON THE OTHER (B)(4). THE SENSOR TEMPERATURE WAS CHANGED TO 42 DEGREES C AND THE SITE TIME TO 4 HRS BEFORE RETURNING THE UNITS TO THE CUSTOMER. ACCORDING TO THE CUSTOMER THE USER HAS RECEIVED PROPER TRAINING AND THE OPERATORS MANUAL WAS FOLLOWED. THIS INJURY IS EVALUATED AS REPORTABLE, BUT BASED ON THE INFORMATION CURRENTLY AVAILABLE THE INJURY IS ONLY EVALUATED AS MINOR AS IT DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY, AS DESCRIBED IN THE INSTRUCTIONS FOR THIS FORM.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT TWO PATIENTS RECEIVED SKIN BLISTERS AFTER USING THE TCM4 FOR A SLEEP STUDY. TWO TCM4 MONITORS WERE SENT TO RADIOMETER FOR EVALUATION BUT THE CUSTOMER DID NOT KNOW WHICH OF THE TWO MONITORS WERE USED FOR THE STUDY. THIS REPORT CONCERNS PATIENT REF (B)(6). MDR REPORTS FOR THE OTHER AFFECTED PATIENT WILL BE SUBMITTED WITH MDR REFERENCE 3002807968-2014-00054.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719436 TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 MONITORING SYSTEM LKD RADIOMETER MEDICAL APS TCM4 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other