BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9843

    MDR report key: 372176 · Received January 17, 2002

    Report

    Report Number
    2183646-2002-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2002
    Date of Event
    December 18, 2001
    Report Date
    January 16, 2002
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUSTAINED A MINOR BURN ON THE INDEX FINGER WHILE BEING MONITORED WITH A PULSE OXIMETER, PATIENT CABLE AND SENSOR. PATIENT SUSTAINED BURN FROM THE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9843 PULSE OXIMETER/CO2 DETECTOR CCK NONIN MEDICAL, INC. 9843 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other