BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE OXIMETER

    MDR report key: 86776 · Received April 28, 1997

    Report

    Report Number
    MW1011216
    Event Type
    Other
    Date Received
    April 28, 1997
    Date of Event
    April 23, 1997
    Report Date
    April 23, 1997
    Manufacturer
    OHMEDA
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    7 MO WHITE MALE RECEIVED IN PACU. WHITE BLISTER NOTED ON LEFT RING FINGER. S/P BILATERAL MYRINGOTOMY WITH TUBE INSERTION. DISCOVERED THAT ANOTHER CO'S PULSE OX PROBE HAD BEEN USED WITH THE CO'S PULSE OXIMETER MACHINE WHICH MAY HAVE CAUSED SECOND DEGREE BURN. A LABEL ATTACHED TO PROBE DOES WARN OF POSSIBLE BURN IF USED WITH INCOMPATIBLE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER PULSE OXIMETER DQA OHMEDA 3710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other PHYSIO-CONTROL PROBE