BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICS INFINITY CENTRAL STATION

    MDR report key: 2834119 · Received November 9, 2012

    Report

    Report Number
    1220063-2012-00067
    Event Type
    Death
    Date Received
    November 9, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 30, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CONNECTION OF THE INFINITY CENTRAL STATION (ICS) WITH EMITTER F3_12 DID NOT SHOW THE ALARMS CORRECTLY. THE INCIDENT OCCURRED ON (B)(6) 2012 BETWEEN 5:28 AND 5:35. FIFTEEN OTHER ACTIVE TRANSMITTERS DID NOT SHOW ANY NOTICEABLE PROBLEMS. ON (B)(6), 2012, THE EMITTER F3_12 WAS TESTED WITH A SIMULATOR AND NO NOTICEABLE PROBLEMS WERE FOUND. IT WAS REPORTED THAT THE PT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICS INFINITY CENTRAL STATION PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18267 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO