BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 1082789 · Received July 23, 2008

    Report

    Report Number
    1220063-2008-00023
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR THE DEVICE TO BE REC'D FROM DRAEGER LUBECK FOR EVAL. AS SOON AS THE INVESTIGATION IS COMPLETED, WE WILL REPORT THE RESULTS TO FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED STRONG BURNED SMELL OF PT MONITOR MDS II DURING USE. THE DEVICE WAS SWITCHED OFF AND THE FAILURE WAS REPORTED. THERE WAS NO PT INJURY REPORTED. THE DEVICE WAS SENT TO DRAEGER LUBECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS 13221 028566

    Patients

    Seq Age Sex Outcome Treatment
    1