BEUDAMED
    FDA Adverse Event Summary report: N

    PULSE OXIMETER

    MDR report key: 18935 · Received January 12, 1995

    Report

    Report Number
    MW1004734
    Date Received
    January 12, 1995
    Date of Event
    December 25, 1994
    Report Date
    January 11, 1995
    Manufacturer
    NOVAMETRIX MEDICAL SYSTEMS, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE DEVICE FROM THE PT'S TOE, IT WAS NOTED THAT THERE WAS A BROKEN BLISTER UNDER THE SENSOR. THE RPTR STATED THAT IT IS NOT CLEAR AS TO WHAT EXACTLY HAPPENED. THE PT WAS ON THE BURN UNIT. THE RPTR ALSO STATED THAT ON OTHER BURN PTS PRESSURE SORES HAVE BEEN NOTED IN THE AREA WHERE THE WIRE IS TAPED TO THE SKIN. THESE PROBLEMS HAVE ONLY BEEN NOTED WITH BURN PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER DQA NOVAMETRIX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *