BEUDAMED
    FDA Adverse Event Other Summary report: N

    S/5 ANESTHESIA MONITOR

    MDR report key: 1371272 · Received April 28, 2009

    Report

    Report Number
    9610105-2009-00021
    Event Type
    Other
    Date Received
    April 28, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 28, 2009
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CCL
    PMA / PMN Number
    K051092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CASE, THE PHYSICIANS ON CALL RECOGNIZED THAT THEY HAD NO GAS ANALYSIS ON THE S/5 MONITOR. THIS WAS DUE TO THE SAMPLE LINE OF THE GAS ANALYSIS MODULE BEING INADVERTENTLY ATTACHED TO THE CALIBRATION PORT. AS A RESULT, THE PHYSICIANS WERE UNABLE TO MONITOR END TIDAL CO2 OR OXYGEN, AND WERE UNABLE TO MEASURE THE POTENCY OF GAS DELIVERY. THE FIRST ISSUE WAS WELL MANAGED AS ONLY OXYGEN WAS BEING DELIVERED AND THE RESPIRATORY RATE WAS KNOWN. THE SECOND ISSUE RESULTED IN THE PT RECEIVING TWICE THE AMOUNT OF ANESTHETIC AS INTENDED. WHILE THE CORRECT VALUES WERE DISPLAYED ON THE MONITOR IN THE GAS SETTINGS AREA, THE CAREGIVERS DID NOT RECOGNIZE THAT SEVOFLURANE WAS BEING DELIVERED AT 2% BECAUSE THE AREA THAT PROVIDERS ARE USED TO REFERENCING (END TIDAL CONCENTRATIONS) WAS NOT FUNCTIONING. THE PHYSICIANS PROCEEDED WITH MANUAL VENTILATION AND OXYGEN. IV ANESTHETICS WERE USED TO KEEP PT UNDER ANESTHESIA. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 ANESTHESIA MONITOR PARAMETER MODULES CCL GE HEALTHCARE FINLAND OY E-CIAO-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other