BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 1061340 · Received June 9, 2008

    Report

    Report Number
    1061340
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 30, 2008
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING OR PROCEDURES, ANESTHESIOLOGIST WOULD OBSERVE FLUCTUATIONS IN PATIENT TEMPERATURES ON GE SOLAR PATIENT MONITOR WITH PDM FROM 3-10 DEGREES WHILE ESU IN USE. "TEMP CAL FAILURE" MESSAGES ALSO OBSERVED. TEMPERATURE PROBES SWAPPED OUT, BUT NO EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR, MULTI-PARAMETER MODULE MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *