BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY CENTRAL STATION

    MDR report key: 3143197 · Received May 29, 2013

    Report

    Report Number
    1220063-2013-00027
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 A PT EXPIRED WHILE MONITORED BY A DELTA BEDSIDE MONITOR AND AN INFINITY CENTRAL STATION (ICS). THERE HAS BEEN NO MACHINE MALFUNCTION ALLEGED AT THIS TIME. DRAGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234454 INFINITY CENTRAL STATION PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS25707 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO