BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 7831976 · Received August 30, 2018

    Report

    Report Number
    7831976
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 24, 2018
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE OPENED A NEW PATIENT CARE UNIT, AND WE ORDERED THE NEW MODEL B850 OF GE PATIENT MONITORS. AFTER INSTALLATION AND INTEGRATION TESTING OF THE MONITORS INTO THE EMR, WE VERIFIED THAT THE MONITORS ARE SENDING DATA. ONCE WE CONNECTED THE VENTILATOR TO THE MONITOR FOR INTEGRATION PURPOSES, AS WE DO WITH THE OLDER MODEL SOLAR 8000I THAT WE USE ALL OVER THE HOSPITAL, THE NEW B850 IS CHANGING THE VENT HL7 DATA BEING SENT FROM THE MONITOR TO THE EMR. CAUSING DATA LOSS. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE NEW MODELS B850 HAVE A NEW HL7 STRING FOR FEW OF THE PARAMETERS AND MAKING IT VERY HARD TO INTEGRATE IN THE SAME HOSPITAL AS THE OLDER MODELS. THE SOLAR 8000I HAVE AN HL7 STRING THAT IS DIFFERENT THAN THAT OF THE B850.

    Description of Event or Problem · 1

    WE OPENED A NEW PATIENT CARE UNIT, AND WE ORDERED THE NEW MODEL B850 OF GE PATIENT MONITORS. AFTER INSTALLATION AND INTEGRATION TESTING OF THE MONITORS INTO THE EMR, WE VERIFIED THAT THE MONITORS ARE SENDING DATA. ONCE WE CONNECTED THE VENTILATOR TO THE MONITOR FOR INTEGRATION PURPOSES, AS WE DO WITH THE OLDER MODEL SOLAR 8000I THAT WE USE ALL OVER THE HOSPITAL, THE NEW B850 IS CHANGING THE VENT HL7 DATA BEING SENT FROM THE MONITOR TO THE EMR. CAUSING DATA LOSS. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE NEW MODELS B850 HAVE A NEW HL7 STRING FOR FEW OF THE PARAMETERS AND MAKING IT VERY HARD TO INTEGRATE IN THE SAME HOSPITAL AS THE OLDER MODELS. THE SOLAR 8000I HAVE AN HL7 STRING THAT IS DIFFERENT THAN THAT OF THE B850.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674988 CARESCAPE PATIENT MONITOR MHX GE HEALTHCARE B850

    Patients

    Seq Age Sex Outcome Treatment
    1 36135 DA Unknown