BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 1969076 · Received January 18, 2011

    Report

    Report Number
    1220063-2010-00100
    Event Type
    Death
    Date Received
    January 18, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 A PATIENT WAS MONITORED BY A DELTA MONITOR AND ONLY THE SPO2 SENSOR WAS CONNECTED. MEDICAL STAFF REPORTED THAT THE PATIENT REPEATEDLY PULLED THE SPO2 SENSOR OFF FROM HIS FINGER, WHICH RESULTED IN MANY ALARMS. THE SPO2 ALARM WAS THEN SWITCHED OFF BY THE USER. DURING THE ONSITE EVALUATION, NO MALFUNCTION OF THE DELTA MONITOR WAS IDENTIFIED. THERE WAS A PATIENT DEATH REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAGER MEDICAL SYSTEMS, INC. (IT/M) UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO