BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 2474585 · Received February 28, 2012

    Report

    Report Number
    1220063-2012-00016
    Event Type
    Death
    Date Received
    February 28, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 WHILE BEING MONITORED WITH A DELTA MONITOR AND ICS CENTRAL STATION, A PT CODED AND COULD NOT BE REVIVED. THE USERS REPORTED THAT THE WHILE SOME ALARMS WERE GENERATED, SEVERAL ALARMS INCLUDING SPO2 WERE LATER FOUND TO HAVE BEEN SET TO OFF AND AS A RESULT THE STAFF REPORTEDLY WAS NOT ALERTED IN A TIMELY MANNER THAT THE PT'S CONDITION WAS DETERIORATING. A DRAEGER SERVICE TECH WAS DISPATCHED TO CHECK THE DELTA MONITOR, THE IDS, AND THE ICS CENTRAL STATION. THE TSR REPORTED THAT WHEN HE ARRIVED, THE DELTA MONITOR HAD BEEN DISCHARGED AND THEREFORE THE ALARM HISTORY WAS GONE. THE ICS HAS REMAINED IN USE AND THE IDS AND DELTA WERE REPORTEDLY CLEARED FOR RETURN TO USE AFTER THE DRAEGER TECH'S VISIT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death