BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-NOX

    MDR report key: 19606545 · Received June 25, 2024

    Report

    Report Number
    3010396502-2024-00001
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 4, 2024
    Report Date
    June 25, 2024
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED CLAIMING THAT THE PRO-NOX SYSTEM WAS DELIVERING A HIGHER CONCENTRATION THAN EXPECTED. UPON INITIATING A FACETIME CALL WITH THE FACILITY, IT WAS DISCVOERED THAT THE DEVICE WAS NOT CONNECTED TO AN APPROPRIATE BREATHING CIRCUIT AND THE INOUT PRESSURE ON THE N20 WAS SET OUTSIDE OF THE DEVICE TOLERANCE. THE VARIABLE PRESSURE REGULATOR USED WAS NOT PROVIDED BY CARESTREAM AMERICA, AND THE MANUFACTURER RECOMMENDS THE USE OF A PRE-SET REGULATOR. THE TESTING SET-UP METHOD WAS ALSO NOT SET UP ACCORDING TO MANUFACTURER GUIDELINES AND PARIED WITH THE INCORRECT CIRCUIT WOULD NOT ACCURATELY ANALYZE THE OUTPUT OF THE DEVICE. THIS ISSUE WAS BROUGHT UP WITH THE DOCTOR IN THE PAST AND TRAINING AND INFORMATION WAS PROVIDED, BUT NO CHANGES WERE MADE. THE DEVICE WAS RETURNED AND UNDEWENT TESTING AS-IS. THE TESTING DID NOT FIND AS ISSUES WITH THE DEVICE, ALL FUNCTIONS OPERABLE AND WITHIN SPECIFICATIONS. THE REPORTED DEVICE MALFUNCTION BY THE USER WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    GREETINGS I AM A PHYSICIAN ANESTHESIOLOGIST. MY NAME IS DR. (B)(6). I GRADUATED FROM (B)(6) IN 2004. THEN THE (B)(6) IN 2010. I FINISHED MY RESIDENCY AT (B)(6) IN 2014, AND I FINISHED MY PEDIATRIC ANESTHESIA FELLOWSHIP AT (B)(6) HOSPITAL IN 2015. I WORK PART TIME AS AN ANESTHESIOLOGIST IN THE (B)(6) AREA FOR (B)(6) AND (B)(6) HOSPITAL. I ALSO OWN A MEDICAL SPA CALLED (B)(6). (B)(6) SPECIALIZES IN HAIR REMOVAL WITH PAIN RELIEF. WE OFFER NITROUS OXIDE FOR OUR WAXES, LASERS, ELECTROLYSIS, AND TATTOO REMOVAL. I USE TWO DIFFERENT TYPES OF NITROUS OXIDE MACHINE THE NITRONOX AND THE PRONOX. BOTH MACHINES CLAIM TO OFFER 50% NITROUS OXIDE AND 50% OXYGEN. I HOOK THESE MACHINES UP TO DATEX OHMEDA GAS ANALYZERS REGULARLY AND TEST THEM WHILE I GET WAXED OR LASERED MYSELF. IN THE ANESTHESIA WORLD WE DO NOT BELIEVE THAT OUR MACHINES DELIVER WHAT THEY CLAIM. WE CONTINUOUSLY MONITOR THE INPUT FROM MACHINES AND THE OUTPUT FROM PATIENTS DURING ANESTHETICS BY USING GAS ANALYZERS AND WE TITRATE THE MACHINES TO THE GAS ANALYZER. I HAVE THREE PRONOX MACHINES AND ONE NITRONOX MACHINE. THE NITRONOX MACHINE CONSISTENTLY UNDERPERFORMS. IT WAS DESIGNED WITH AN OBLIGATORY OXYGEN LEAK. ON THE GAS ANALYZER IT CONSISTENTLY DELIVERS BETWEEN 45-47% NITROUS OXIDE. THIS COMPLAINT IS NOT ABOUT THE NITRONOX. I HAVE HAD THAT MACHINE FOR 3 YEARS, AND EVERY TIME I TEST IT, IT GIVES THE SAME NUMBERS. I BELIEVE THE PRONOX BY CARESTREAM IS A DANGEROUS MACHINE AND I BELIEVE THAT CARESTREAM DOES NOT KNOW HOW TO TEST ITS MACHINES AND GASLIGHTS ME WHEN I SEND THEM VIDEOS AND EXPLAIN THE PROBLEM. EARLIER THIS WEEK A REPLACEMENT PRONOX READ 84% ON INSPIRATION. THIS IS A HYPOXIC GAS MIXTURE. ANY MACHINE MUST DELIVER 21% OXYGEN. ANYTHING LESS THAN THAT CAN KILL YOU! IT WAS NOT DELIVERING OXYGEN AT ALL AND IT WAS NOT ALARMING. I HAVE SENT VIRTUALLY EVERY MACHINE THAT I HAVE RECEIVED FROM PRONOX BACK BECAUSE THE GAS MIXTURES WERE OFF. THIS WAS THE HIGHEST I RECORDED. OF THE OTHER TWO MACHINES I CURRENTLY HAVE, ONE IS MEASURING AS HIGH AT 70% ON INSPIRATION, AND THE OTHER IS AT 57% (THIS IS CONSIDERED WITHIN RANGE BY CARESTREAM). (B)(6) HAS BEEN OPEN FOR 6 YEARS. I FIND THAT WHEN THE PRONOX ARRIVES IT IS WITHIN RANGE, AND THEN WITHIN A YEAR OR TWO THE VALVES START TO STICK OR SOMETHING, AND THEY START GETTING MORE AND MORE OUT OF RANGE. SO A COUPLE TIMES A YEAR I AM SENDING AND RECEIVING MACHINES FROM THEM. THEY BLAME ME FOR THE DEFECTS. THEY SAY THAT THAT MY GAS REGULATORS OR OFF, OR IT IS THE WAY I MEASURE THE GASSES. THEY CLAIM NOTHING IS WRONG WITH THE MACHINES AND THAT THEY PASS ALL OF THEIR INTERNAL TESTS. I RECENTLY ASKED THEM HOW THEY TEST THE MACHINES. THEY SAID THEY WOULD SEND ME THE DETAILS. THEY HAVEN'T. MEANWHILE, THE NITRONOX, THEIR COMPETITOR, DOES NOT HAVE THE SAME PROBLEMS. ONE ISSUE I AM HAVING WITH THE PRONOX IS THAT THE ALARMS DON'T CONSISTENTLY WORK. IF THOSE MACHINES SEE INCREASED NITROUS PRESSURE IT SHOULD ALARM. IF THE OXYGEN IS LOW, IT SHOULD ALARM. BUT THE ALARMS ARE THE FIRST THING TO FAIL. I DO NOT BELIEVE I WAS GETTING ANY OXYGEN WHEN THE INSPIRATION OF NITROUS SHOWED 89%. WHEN I BRING THIS TO THEIR ATTENTION, THEY CLAIM THAT THERE ARE (B)(4) PRONOX MACHINES IN CIRCULATION IN HOSPITALS AND OFFICES. MAYDAY!! THESE MACHINES NEED CLOSE MONITORING. THEIR OUTPUT IS INCONSISTENT AND CAN LEAD TO HYPOXIC GAS MIXTURES LEADING TO LOSS OF CONSCIOUSNESS, STROKES OR EVEN DEATH. I DID THESE TESTS ON MYSELF WITH A ONE WAY MOUTH PIECE HOOKED UP TO A GAS ANALYZER. I CAN SEND YOU VIDEOS. REFERENCE REPORTS: MW5154631, MW5154632, MW5154633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449133 PRO-NOX PRO-NOX BZR O-TWO MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female