BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR

    MDR report key: 2267005 · Received September 20, 2011

    Report

    Report Number
    2267005
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 14, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    CLINICIANS REPORTED ALARMS BETWEEN THE VENTILATOR AND MONITORING WERE NOT FUNCTIONING AFTER BIOMED UPGRADED THE GE SOLAR SOFTWARE VERSION 4E AND 4F TO GE SOLAR VERSION 5.3. INITIAL TROUBLESHOOTING WAS UNSUCCESSFUL.INVESTIGATION REVEALED THAT THE VERSION 5.3 SOFTWARE CANNOT RECEIVE SERIAL DATA FROM THE OCTANET (WHICH SERVES AS THE INTERFACE BETWEEN THE SOLAR MONITOR AND A VENTILATOR). RESOLUTION CAME AFTER REPLACING THE OCTANET WITH A UNITY ID AND THERE HAVE NOT BEEN FURTHER REPORTED ISSUES. THERE IS NO OBVIOUS DOCUMENTED INFORMATION IN GE MANUAL MENTIONING COMPATIBILITY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR MONITOR, PHYSIOLOGICAL, SOFTWARE MHX GE HEALTHCARE SOLAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NONE KNOWN TO HAVE CONTRIBUTED