BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRONICS 920M

    MDR report key: 2231585 · Received August 22, 2011

    Report

    Report Number
    2183646-2011-00003
    Event Type
    Other
    Date Received
    August 22, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 12, 2011
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO NONIN MEDICAL INC. WHERE THE PRODUCT WAS INSPECTED AND TESTED (B)(4) 2011 FOR DEFECT, NO MALFUNCTION WAS DISCOVERED. THE MONITOR AND SENSOR WERE TESTED IN AN ELEVATED TEMPERATURE CHAMBER AT 35 DEGREES CELSIUS AND THE APPLIED SENSOR TEMPERATURE WAS MONITORED FOR A TEMPERATURE RISE WHILE OPERATING ON A PATIENT SIMULATOR, NO TEMPERATURE RISE ABOVE AMBIENT WAS RECORDED DURING THE TEST.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING THAT AN 7000I SENSOR CONNECTED TO A 920MP PULSE OXIMETER ALLEGEDLY BURNED A CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS 920M PULSE OXIMETER DQA NONIN MEDICAL, INC. 920M/7000I

    Patients

    Seq Age Sex Outcome Treatment
    1