BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRONICS

    MDR report key: 1523810 · Received November 6, 2009

    Report

    Report Number
    2183646-2009-00006
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    September 19, 2009
    Report Date
    November 4, 2009
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K893221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES THAT HE WAS USING A PULSE OX FOR AN OVERNIGHT STUDY AND HAD THE OXIMETER LAYING ON HIS STOMACH. PT CLAIMS HE WOKE UP TO A BURNING SENSATION ON HIS STOMACH THAT WAS CAUSED BY THE OXIMETER. PT WAS USING A FINGER SENSOR PART # UNK. IN ADDITION TO THE OXIMETER, PT WAS USING AN OXYGEN CONCENTRATOR MADE BY AIRSEP. AS STATED BY (B)(6) - OPERATIONS MANAGER, REPORTING THE ISSUE, SHE STATES THERE WAS MARKS ON HIS (PT'S) STOMACH. IN ADDITION, (B)(6) STATED THERE ARE NO SIGNS OF THERMAL DAMAGE TO THE UNIT OR ANY THERMAL ODORS. SHE STATES THAT THE CARRYING BAG SMELLS OF CIGARETTE SMOKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other