BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY CENTRAL STATION (ICS)

    MDR report key: 862768 · Received June 8, 2007

    Report

    Report Number
    1220063-2007-00008
    Event Type
    Death
    Date Received
    June 8, 2007
    Date of Event
    May 4, 2007
    Report Date
    June 7, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED WITH THE COMPLAINT NOTIFICATION, THE ROOT CAUSE FOR THE EVENT WAS REPORTED BY THE CUSTOMER AS "USER ERROR" AND THAT THERE WAS NO MALFUNCTION OF THE ICS DEVICE. AS A RESULT OF THE INFO RECEIVED FROM THE CUSTOMER, THE MFR IS NOT PLANNING ANY CORRECTIVE ACTION.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. RECEIVED INFO THAT AN EVENT OCCURRED SOMETIME INVOLVING OUR INFINITY CENTRAL STATION (ICS) WITH THE TELEMETRY OPTION AT A CUSTOMER SITE. THE CUSTOMER HAD INDICATED THAT THE ORIGINAL TELEMETRY TRANSMITTER ASSIGNED TO A PT WAS MISPLACED, SO THE ATTENDING CLINICIAN PLACED A DIFFERENT TRANSMITTER ON THE PT AND DID NOT PROPERLY CONFIGURE OR DOCUMENT THE NEW TRANSMITTER ASSIGNMENT TO THE CENTRAL STATION MONITOR. THE PT CODED AND THE NETWORK PAGING SYSTEM USED AT THE CUSTOMER SITE DIRECTED THE ATTENDING CLINICIANS TO THE WRONG ROOM. THE PT WAS CLASSIFIED AS A DNR AND THE STAFF DID NOT TRY TO REVIVE THE PT, AS A RESULT, THE PT WAS PRONOUNCED DECEASED. THE CUSTOMER INDICATED THAT THE ICS PERFORMED AS IT WAS DESIGNED AND THE HOSPITAL IS NOT QUESTIONING THE FUNCTION OF THE DRAEGER MEDICAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY CENTRAL STATION (ICS) CENTRAL STATION MONITOR DRT DRAEGER MEDICAL SYSTEMS, INC. MS20261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death