BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 4356209 · Received November 7, 2014

    Report

    Report Number
    1523456-2014-00007
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 WAS 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)(4). MDR REPORTS FOR THE OTHER AFFECTED PATIENT WILL BE SUBMITTED WITH MDR REFERENCE 3002807968-2014-00055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720852 TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 MONITORING SYSTEM LKD RADIOMETER MEDICAL APS TCM 4 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other