BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANESTHESIA GAS MONITOR

    MDR report key: 10445 · Received December 10, 1993

    Report

    Report Number
    MW1000069
    Event Type
    Other
    Date Received
    December 10, 1993
    Date of Event
    November 4, 1993
    Report Date
    November 29, 1993
    Manufacturer
    OHMEDA
    Product Code
    CCL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OHMEDA MEDICAL SYSTEMS DIV. 1315 W CENTURY DR, LOUISVILLE, CO 80027. OHMEDA HAS RECEIVED REPORTS IN WHICH THE OHMEDA RASCAL II ANESTHETIC GAS MONITOR HAS DISPLAYED THE INCORRECT ANESSTHETIC AGENT. THIS WILL OCCUR WITH THE RASCAL II WHEN ALL OF THE FOLLOWING CONDITIONS ARE MET: IT IS USED FOR 45 CONTINUOUS (CUMULATIVE) HRS WITHOUT HAVING THE POWER TURNED OFF, AND A SINGLE AGENT HAS BEEN MONITORING EXCLUSIVELY (NO AGENT MIXTURES IDENTIFIED) DURING THE 45 HR PERIOD, AND THE AGENT BEING MONITORED IS THEN CHANGED TO A DIFFERENT AGENT AFTER 45 HRS. WHEN ALL OF THE ABOVE CONDITIONS ARE MET, THE RASCALL II WILL ONLY DISPLAY THE LAST SINGLE AGENT MONITORED AT THE END OF THE CONTINUOUS 45 HR PERIOD. THIS CONDITION IS CAUSED BY THE OVERFLOW OF A SOFTWARE CONTROLLED COUNTER. OHMEDA WILL BE ARRANGING FOR A SVC REP TO VISIT YOUR FACILITY TO UPDATE THE SOFTWARE IN ANY AFFECTED DEVICES. THERE WILL BE NO CHARGE FOR THIS UPDATE. USERS OF AFFECTED RASCAL II ANESTHETIC GAS MONITORS SHOULD BE MADE AWARE OF THIS NOTICE. ALTHOUGH REPORTS RECEIVED TO DATE HAVE NOT INVOLVED PT INJURY, WITHOUT TIMELY IDENTIFICATION OF THE DISPLAYED INCORRECT AGENT, THE CONDITION OF THE PT COULD BE ADVERSELY AFFECTED. THEREFORE, IT IS IMPERATIVE, AS ALWAYS, THAT USERS OBSERVE PT VITAL SIGNS AND APPLICABLE OUTPUTS FROM OTHER MONITORS. YOU MAY CONTINUE TO USE THE RASCAL II. TO AVOID THE POSSIBILITY OF THIS CONDITION UNTIL AFFECTED DEVICES HAVE BEEN UPDATED, SIMPLY TURN THE RASCAL II OFF AT THE END OF THE DAY. A WARM UP WILL BE REQUIRED AS DESCRIBED IN THE OPERATION AND MAINTENANCE MANUAL UPON POWERING UP THE NEXT DAY. SHOULD THIS CONDITION OCCUR DURING USE, IT MAY BE IMMEDIATELY CORRECTED BY TURNING THE RASCAL OO OFF AND THEN BACK ON. ONLY DEVICES WITH SERIAL NUMBERS FZAU00001 TO FZAU00394, FZAV00395 TO FZAV00886 AND FZAW00887 TO FZAW01697, AND SOFTWARE VERSION 1.10 OR LOWER ARE AFFECTED. THE SERIAL NUMBER IS LOCATED ON THE BACK OF THE DEVICE, WHILE THE SOFTWARE VERSION IS DISPLAYED WHEN THE DEVICE IS ON AND PLACED IN THE STANDBY MODE. THE FDA HAS BEEN INFORMED OF THIS RECALL. IF YOU SHOULD HAVE ANY FURTHER QUESTIONS REGARDING THIS INFO, PLEASE CONTACT CATHY JOHNSON AT 1-800-521-0086. THANK YOU FOR YOUR COOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA GAS MONITOR CCL OHMEDA RASCAL II

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other