BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 2980798 · Received February 21, 2013

    Report

    Report Number
    1220063-2013-00009
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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 SPO2 SENSOR FELL OFF THE PT'S FINGER, WHICH WAS NOT NOTICED BY THE USERS. THE MONITOR REPORTEDLY CONTINUED TO DISPLAY 100% O2 SATURATION AND DID NOT ALARM. IT WAS REPORTED THAT THE PT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76880 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18597 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO