BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY CENTRAL STATION

    MDR report key: 1183423 · Received October 2, 2008

    Report

    Report Number
    1220063-2008-00030
    Event Type
    Death
    Date Received
    October 2, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 12, 2008
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRAGER INFINITY CENTRALSTATION INSTRUCTIONS FOR USE EXPLAINS THAT THE SOUND LEVEL OF THE INFINITY CENTRALSTATION SHOULD BE SET ACCORDING TO THE SOUND LEVEL OF THE CARE UNIT (AMBIENT NOISE). IN SECTION 1, PAGE 1-2 OF THE INSTRUCTIONS FOR USE IT STATES THAT THE INFINITY CENTRALSTATION CPU MUST BE PLACED SO THAT IT CAN BE HEARD EASILY IF THE EXTERNAL SPEAKER BECOMES NON-FUNCTIONAL. IN ADDITION, ON PAGE 4-3 OF THE INSTRUCTIONS FOR USE THERE IS A WARNING STATEMENT THAT EXPLAINS TO ALWAYS SET THE ALARM VOLUME SO IT CAN BE HEARD DURING THE BUSIEST PERIODS OF THE DAY. THE CUSTOMER HAS CONFIRMED THAT THERE WAS NO ALLEGED MACHINE MALFUNCTION. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALARMS WERE GENERATED AT THE ICS FOR TELEMETRY BED T5288 BEGINNING AT 5:27 PM BUT THE ALARMS WENT UNNOTICED BY THE HOSPITAL STAFF FOR AN UNDETERMINED AMOUNT OF TIME. WHEN THE STAFF RESPONDED TO THE PT, THE PT WAS EXPERIENCING CARDIAC DISTRESS AND A NEGATIVE PT OUTCOME WAS REPORTED. THE ALARM VOLUME AT THE ICS WAS REPORTEDLY SET TO 70% AND THE ICS HAS EXTERNAL AMPLIFIERS AND CEILING SPEAKERS REPORTEDLY INSTALLED BY DRAEGER TO ENHANCE AUDIBLE ALARM DETECTION. THE CUSTOMER IS REQUESTING RECOMMENDATIONS FROM DRAGER REGARDING ALARM VOLUME SETTINGS AT THE ICS AND FOR THE SUPPLEMENTAL AMPLIFIERS AND SPEAKERS TO ENHANCE ALARM DETECTION. THE CUSTOMER HAS CONFIRMED THAT THERE WAS NO ALLEGED MACHINE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY CENTRAL STATION PATIENT MONITOR DSI DRAGER MEDICAL SYSTEMS, INC. (IT/M) DF0C86

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK