BEUDAMED
    FDA Adverse Event Death Summary report: N

    M300

    MDR report key: 2234147 · Received August 30, 2011

    Report

    Report Number
    1220063-2011-00037
    Event Type
    Death
    Date Received
    August 30, 2011
    Report Date
    August 2, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 PATIENT WAS ADMITTED TO THE TELEMETRY FLOOR ON (B)(6), 2011 AND WAS BEING MONITORED BY AN M300 AND ICS CENTRAL STATION. IT WAS REPORTED THAT AT SOME UNKNOWN TIME BETWEEN (B)(6), 2011 AND (B)(6), 2011, THE ICS DISPLAYED A 'BED DISCONNECTED' MESSAGE FOR THE M300 IN QUESTION. IT WAS REPORTED THAT THE 'BED DISCONNECTED' MESSAGE WENT UNNOTICED BY THE USERS. IT WAS FURTHER REPORTED THAT WHEN A NURSE WENT TO THE PATIENT ROOM TO CHECK ON THE PATIENT ON (B)(6) MORNING, IT WAS DISCOVERED THAT THE PATIENT HAD EXPIRED. IT WAS REPORTED THAT THE USER SUSPECTED THAT THE M300 MAY HAVE DISCHARGED THE PATIENT WITHOUT USER INTERVENTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M300 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS25755 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO