BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLAR 8000I

    MDR report key: 1756926 · Received July 8, 2010

    Report

    Report Number
    2124823-2010-00063
    Event Type
    Other
    Date Received
    July 8, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K012467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATED THE CIC (CENTRAL STATION) LOG FILES FOR THE SOLAR 8000M BED IN QUESTION BETWEEN 04:30 AND 06:00, WHICH INDICATE THAT AN ECG LEADS FAIL ALARM OCCURRED AT A SYSTEM WARNING LEVEL AT 04:44:22 AND AN RR LEADS FAIL AT 04:44:22. CIC LOGS ALSO INDICATE THAT WHEN THE BED ALARMED FOR LEADS FAIL, ANOTHER BED WAS ALARMING FOR SPO2 LO AT WARNING LEVEL. THIS ALARM IS AT A HIGHER PRIORITY AND WOULD SOUND INSTEAD OF THE AUDIBLE SYSTEM WARNING ALARM FOR THE BED IN QUESTION. THE PT VIEWER WINDOW WOULD HAVE A YELLOW BORDER AND LEADS FAIL MESSAGE DISPLAYED, WITH NO ECG WAVEFORM. BASED ON THE INFO AVAILABLE, THE SYSTEM PERFORMED TO SPECIFICATIONS. IT WAS ALSO DETERMINED DURING THE INVESTIGATION THAT THE CUSTOMER IS USING A WIRELESS ECG DEVICE MFG BY LIFESYNC WHICH IS NOT SUPPORTED BY GE HEALTHCARE. THE CUSTOMER WAS INFORMED THAT GE HEALTHCARE DOES NOT SUPPORT THE USE OF THE WIRELESS LIFESYNC ECG DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS NO ALARM FOR A LEADS FAIL EVENT BETWEEN 04:40 AND 06:00. THE PT REPORTEDLY WENT INTO LEADS FAIL, AND A VISUAL SYSTEM WARNING ALARM FOR LEADS FAIL WAS SEEN AT 04:43 AND RR LEADS FAIL AT 04:44. THERE WERE ALLEGEDLY NO OTHER ALARMS FOR LEADS FAIL. AT 0556, SPO2 ALARMED FOR A LOW SATURATION OF 63%, WHICH WAS SET TO A WARNING LEVEL. AT THAT TIME IT WAS NOTICED THAT THE PT WAS UNRESPONSIVE. THE BIOMED STATES THAT THE PT IS CURRENTLY EXHIBITING NEUROLOGICAL DEFICITS RELATED TO LOW SATURATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 8000I PATIENT MONITOR DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R| S