BEUDAMED
    FDA Adverse Event Other Summary report: N

    XPOD

    MDR report key: 535976 · Received July 20, 2004

    Report

    Report Number
    2183646-2004-00001
    Event Type
    Other
    Date Received
    July 20, 2004
    Date of Event
    July 10, 2004
    Report Date
    July 19, 2004
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    NONIN WAS NOTIFIED BY CUSTOMER IN 2004 OF EVENT THAT OCCURRED AT A CLINIC. THE X-POD WAS LOCATED ON THE BED DURING A SLEEP STUDY AND GOT HOT CAUSING A BURN ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPOD OEM EXTERNAL PULSE OXIMETRY DQA NONIN MEDICAL, INC. 3011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other