BEUDAMED
    FDA Adverse Event Summary report: N

    INTELLIVUE

    MDR report key: 2614429 · Received June 11, 2012

    Report

    Report Number
    2614429
    Date Received
    June 11, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 11, 2012
    Manufacturer
    PHILIPS
    Product Code
    LKD
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE NOTED THAT THE BILATERALLY ANTERIOR APICALS ON THE PATIENT APPEAR TO HAVE IRRITATION AND REDNESS CAUSE BY THE 32MM FIXATION RINGS FOR THE PHILIPS TCG10 SENSOR (RADIOMETER SENSOR 84). THIS DEVICE IS USED TO MEASURE TRANCUTANEOUS PCO2 ON INFANTS. THE REDNESS COULD HAVE BEEN CAUSED BY THE ADHESIVE. ACCORDING TO STAFF, THIS PARTICULAR PATIENT'S CONDITION CAUSED THE ADHESIVE TO NEED TO BE RE-APPLIED MORE OFTEN THAN NORMAL. THEREFORE, THE FIXATION RING HAD TO BE REMOVED AND RE-APPLIED MORE FREQUENTLY THAN NORMAL. THE ACT OF REMOVING AND RE-APPLYING THE FIXATION RING MAY HAVE CAUSED THE REDNESS. HOWEVER, WE DID EXPERIENCE ANOTHER BABY GETTING A SMALL BURN FROM THIS SENSOR, SO WE WOULD LIKE PHILIPS AND RADIOMETER TO INVESTIGATE THIS INCIDENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MONITOR, TRANCUTANEOUS LKD PHILIPS TCG10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO