BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 1811855 · Received August 18, 2010

    Report

    Report Number
    1220063-2010-00038
    Event Type
    Death
    Date Received
    August 18, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 13, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR FAILED TO ALARM. THE DEVICE WAS TESTED ON SITE AND WORKED WITHIN SPECIFICATION. IT WAS REPORTED THAT THE PT DIED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO