BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST AIR/OXYGEN MIXER 3500CP-C

    MDR report key: 7701205 · Received July 18, 2018

    Report

    Report Number
    2020676-2018-00011
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 19, 2018
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER EVALUATION RESULTS: VISUAL INSPECTION RESULTS : THE 3500 CP-C MIXER WAS VISUALLY INSPECTED AND THE FI02 KNOB WAS FOUND TO BE TURNED TOO FAR ALONG THE PROPORTIONAL SHAFT SO AS TO NOT INTERACT WITH THE STOP PIN. MECHANICAL TESTING RESULTS: THE MIXER AS RECEIVED FOUND THE FI02 READINGS WERE OUT OF SPECIFICATION DUE TO THE FIO2 KNOB WAS ONE FULL ROTATION COUNTERCLOCKWISE OF ITS INTENDED POSITION WHEN THE UNIT WAS RECEIVED FROM THE CUSTOMER. CONCLUSIONS RESULTS: THE FAILURES OBSERVED DURING FULL TESTING PER DOC. 150009 RECORDED IN THE PRODUCT EVALUATION SECTION OF THIS REPORT ARE DUE TO THE FAILURE OF THE DEVICE BEING MAINTAINED AND HANDLED PROPERLY BY THE USER. USER'S MANUAL STATES: THE 3500CP-C MIXER IS A "PRECISION GAS MIXING DEVICE INTENDED FOR USE WITH MEDICAL BREATHING AIR AND MEDICAL BREATHING OXYGEN ONLY" PER THE USER'S MANUAL. ALSO STATED IN THE USER'S MANUAL IS THE "USER OF THE SECHIRST AIR/OXYGEN MIXER SHALL HAVE SOLE RESPONSIBILITY FOR ANY MALFUNCTION, WHICH RESULTS FROM IMPROPER USAGE. A REVIEW OF THE DEVICE HISTORY RECORDS AND THE SERVICE HISTORY RECORDS WAS PERFORMED AND FOUND THAT THE MIXER MODEL 3500CP-C S.N.(B)(4) WAS MANUFACTURED ON 06/14/1994. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. A REVIEW OF THE MIXER'S SERVICE HISTORY FOUND THAT IT WAS LAST OVERHAULED BY SECHRIST ON 5/31/2017 AND TESTED WITHIN SPECIFICATION UPON RELEASE TO CUSTOMER.

    Description of Event or Problem · 1

    DATE OF OCCURRENCE: (B)(6) 2018. PATIENT WAS BEING TREATED FOR CABG "WENT ON BYPASS, THE STAFF NOTICED THE PATIENT'S ARTERIAL BLOOD WAS NOT FULLY OXYGENATED WHILE AT THE MAXIMUM FI02 SETTING. THEY WERE ABLE TO TROUBLESHOOT THAT THE ISSUE WAS WITH THE MIXER AND QUICKLY CHANGED IT OUT WITHIN A MINUTE OF DIAGNOSIS, SO THERE WASN'T ANY DELAY IN TREATMENT. PATIENT WAS FINE DURING THE PROCEDURE AS WELL AS DOING FINE NOW. AFTER THE EVENT THE BIOMED EVALUATED THE MIXER AND OBSERVED THE "KNOB CAN TURN PAST THE 21% STOP". THE CUSTOMER REPORTED THAT A PERFORMANCE VERIFICATION WAS COMPLETED PRIOR TO THE MIXER BEING PLACED INTO SERVICE WITH THE PATIENT. THE CUSTOMER REPORTED THE LAST PREVENTATIVE MAINTENANCE THAT WAS COMPLETED ON THE MIXER WAS DONE ON JUNE 8, 2018. SEE MFR # 2020676-2018-00010 FOR THE SECOND REPORT FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542474 SECHRIST AIR/OXYGEN MIXER 3500CP-C AIR/OXYGEN MIXER 3500 CP-C DTZ SECHRIST INDUSTRIES, INC. 3500CP-C

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR