BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM4 COMBI MODULE

    MDR report key: 10137122 · Received June 10, 2020

    Report

    Report Number
    3002807968-2020-00020
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 13, 2020
    Report Date
    August 14, 2020
    Product Code
    LKD
    PMA / PMN Number
    K043003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INFORMED BY THE RADIOMETER REPRESENTATIVE THAT THE HOSPITAL IS USING SENSOR 54 (ITEM NUMBER: 945-736 MANUFACTURED BY RADIOMETER BASEL AG) WITH FIXATION RING 32 MM (ITEM NUMBER: 5601500 MANUFACTURES BY RADIOMETER BASEL AG) IN COMBINATION WITH THE TCM COMBIM MONITOR. MORE INFORMATION HAS BEEN ASKED FROM RADIOMETER TO THE CUSTOMER FOR THE FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT IS NOT POSSIBLE TO CONCLUDE ON AN INVESTIGATION BASED ON THE AVAILABLE INFORMATION IN THIS CASE. THE OPERATOR'S MANUAL DESCRIBES THAT THE SMALLER N20 FIXATION OR ADHESIVE RING SHOULD BE USED FOR NEONATES. THE SMALLER RING MAY BE MORE GENTLE TO THE SKIN DUE TO THE SMALLER ADHESIVE SURFACE. IT WAS RECOMMENDED TO THE CUSTOMER TO TRY THIS SMALLER RING INSTEAD OF THE 32MM RING FOR THIS PATIENT POPULATION. THE CUSTOMER HAS INFORMED THAT THEY WILL CONTINUE TO USE THE LARGER FIXATION RINGS, DESPITE RADIOMETER'S RECOMMENDATION.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INCIDENT DATE STATED IS BEST ESTIMATION. FURTHERMORE, PLEASE ALSO NOTE CATALOG NUMBER IS BEST ESTIMATION AS THIS INFORMATION IS NOT KNOWN IN THE COMPLAINT. UNFORTUNATELY ALSO THE SERIAL NUMBER, UDI NUMBER AND MANUFACTURING DATE OF THE DEVICE IS STILL UNKNOWN. THE INFORMATION WILL BE ADDED IN A FOLLOW-UP MDR WHEN KNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED BRUISING AND REDNESS ON BOTH LEGS BILATERALLY WHERE THE TCM SITES WERE PLACED ON AN ELGAN (EXTREMELY LOW GESTATIONAL AGES NEWBORN) (B)(6) WEEKS OLD NEWBORN. THE DOCTOR FELT THE SKIN WAS SO CONCERNING AND ORDERED FOR A WOUND CONSULTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602340 TCM4 COMBI MODULE TCM4 COMBI MODULE LKD 902-778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other