BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE CENTRAL STATION ATO MODEL

    MDR report key: 5254910 · Received November 30, 2015

    Report

    Report Number
    2124823-2015-00031
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    October 18, 2015
    Report Date
    January 15, 2016
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K133882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INCORRECTLY FILED AS MDR MFR. REPORT # 2124823-2015-00031 FOR THE CARESCAPE CENTRAL STATION PRODUCT. THE CORRECT MDR MFR. REPORT # IS 3008729547-2016-00002 FOR THE DASH 4000 PRODUCT. AN INITIAL MDR WILL BE SUBMITTED WITH THE CORRECT INFORMATION. THIS REPORT WAS INCORRECTLY FILED AS MDR MFR. REPORT # 2124823-2015-00031 FOR THE CARESCAPE CENTRAL STATION PRODUCT. THE CORRECT MDR MFR. REPORT # IS 3008729547-2016-00002 FOR THE DASH 4000 PRODUCT. AN INITIAL MDR WILL BE SUBMITTED WITH THE CORRECT INFORMATION.

    Additional Manufacturer Narrative · 1

    THOUGH SERIOUS INJURY, THIS IS BEING FILED AS AN USE ERROR REPORT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT BEING MONITORED ON THE DASH PATIENT MONITOR EXPERIENCED A LOW SPO2 CONDITION AND DUE TO A MIX-UP WITH ANOTHER DASH MONITOR, THE SPO2 LOW ALARMS WERE MISTAKEN FOR FALSE ALARMS AND THUS IGNORED. THE CUSTOMER REPORTED AN APPROXIMATELY 15 MINUTE DELAY BEFORE ANYONE RESPONDED; THE PATIENT DID SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786076 CARESCAPE CENTRAL STATION ATO MODEL DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SGJ15161300GA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other