BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE B850

    MDR report key: 4251098 · Received November 5, 2014

    Report

    Report Number
    MW5038998
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 5, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE HAD A PT WHO WAS HAVING NEURO ISSUES, AND WHOSE RESPIRATIONS WERE SLOWING DOWN TO APPROX A RATE OF 5-8 INTERMITTENTLY. HOWEVER THE CENTRAL INFO CENTER (CIC) WAS READING AT ABOUT 30-40 ABOVE THE PT'S ACTUAL RATE. THE MONITOR, BECAUSE IT WAS GIVING A FALSE HIGH READING NEVER ALARMED FOR THIS CONDITION. THE MONITOR AT THE BEDSIDE AND THE CIC BOTH READING RESP RATE: 44 BUT THE PT WAS BREAKING 5/ MIN. RN VERIFIED THIS NUMBER MANUALLY BY USING A PORTABLE CO2 MONITOR, AND CONFIRMED RESP. TO = 5. PT WAS BEING MONITORED ON A B850 S/N# (B)(4), B850 SOFTWARE REV. 2.0.6.2. ALSO IN USE WAS A PT DATA MODULE (PDM), S/N# (B)(4). THE BEDSIDE DEVICE WAS REPORTING TO A CLINICAL INFO CENTER (CIC) S/N# (B)(4), SOFTWARE CA: 5.1.1, OS: 3.0.1, SV:1.1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710078 CARESCAPE B850 B850 MHX GE HEALTHCARE B850
    710079 PT DATA MODULE PMD MHX
    710080 CLINICAL INFO CENTER CIC DSI

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other