BEUDAMED
    FDA Adverse Event Other Summary report: N

    NON REBREATHER O2 MASK FOR HIGH CONCENTRATION

    MDR report key: 1349347 · Received March 13, 2009

    Report

    Report Number
    9680866-2009-00002
    Event Type
    Other
    Date Received
    March 13, 2009
    Date of Event
    January 1, 2009
    Report Date
    March 13, 2009
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THAT THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE HOSPITAL FOR EVALUATION, THE INVESTIGATION OF UNOMEDICAL WAS LIMITED TO THE FOLLOWING SOURCES OF INFORMATION: INTENDED USE OF THE DEVICE. EXAMINATION OF SAMPLES FROM THE CURRENT PRODUCTION. COMPLAINT HISTORY FOR THIS PRODUCT. THE 108-MM IS A STRICT NON-REBREATHER MASK WITH VALVES IN THE MASK GROUND AND AT THE MASK DOME, CLOSING THE PATIENT OFF FROM AMBIENT AIR SUPPLY, WHICH MEANS THAT THE OXYGEN SUPPLY TO THE MASK ALWAYS HAS TO BE SUFFICIENT, AS OTHERWISE THE PT WOULD NOT BE ABLE TO BREATHE AMBIENT AIR. SUFFICIENT OXYGEN SUPPLY IS INDICATED WHEN THE RESERVOIR BAG IS FILLED WITH A VOLUME GREATER THAN THE TIDAL VOLUME OF THE PATIENT PRIOR TO INSPIRATION AND THE BAG IS REPLENISHED WITH THE SAME VOLUME DURING PATIENT'S EXPIRATION. IT IS VERY UNUSUAL TO UTILIZE A HIGH CONCENTRATION, NON-REBREATHER MASK IN A RECOVERY ROOM WITH A PATIENT THAT HAS OBVIOUSLY GOOD SATURATION; AS SUCH DEVICES ARE BUILT TO SUPPLY OXYGEN IN HIGH CONCENTRATION FOR MEDICAL EMERGENCY APPLICATION. EXAMINATION OF CURRENT PRODUCTION SAMPLES INDICATED THAT THE PRODUCT IS MEETING THE SPECIFICATIONS REQUIREMENTS. A 5-YEAR HISTORICAL REVIEW OF COMPLAINTS REVEALED NO SIMILAR REPORTED EVENTS. CONSEQUENTLY, FROM A REGULATORY PERSPECTIVE, THIS IS CONSIDERED TO BE AN ISOLATED EVENT. GIVEN THE ABOVE, WE CAN CONCLUDE THAT THE POSSIBLE ROOT CAUSE OF INSOLATED EVENT WAS A USER ERROR. THIS REPORT WILL BE LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    ON FEBRUARY 19, 2009, UNOMEDICAL INC. WAS INFORMED BY THE (B)(6) MANAGER THAT A LETTER FROM THE (B)(6) REGARDING A SERIOUS INCIDENCE ON A UNOMEDICAL PRODUCT WAS RECEIVED. THE INCIDENCE CONCERNS A PATIENT WHO RECEIVES OXYGEN THERAPY WITH A NON-REBREATHABLE OXYGEN MASK FOR HIGH CONCENTRATION (108MM). AFTER A VISIT TO THE OPERATING THEATRE, THE PT WAS MOVED TO THE RECOVERY UNIT, WHERE HE RECEIVES 10 LITER OXYGEN/MINUTE. AT THE RECOVERY UNIT, THE PT IS OBSERVED TO HAVE A FINE SATURATION, AND THEREFORE, THEY REDUCE THE OXYGEN FLOW TO "BELOW 8 LITERS/MINUTE". AFTER THIS ACTION, THE PT IS VERY HEAVILY SLEEPING. AN ARTERIA BLOOD GAS SHOWS INCREASED CO2. THE PATIENT IS MOVED TO ICU WHERE HE ONCE AGAIN RECOVERS. THE INCIDENCE TOOK PLACE AT (B)(6) AT A RECOVERY UNIT, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON REBREATHER O2 MASK FOR HIGH CONCENTRATION OXYGEN MASK BYG UNOMEDICAL INC. 108MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention