BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONSAI OXYGEN CONSERVER

    MDR report key: 6905811 · Received September 29, 2017

    Report

    Report Number
    1062191-2017-00010
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    INOVO INC
    Product Code
    NFB
    UDI-DI
    00814470020037
    PMA / PMN Number
    K070740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED TO PROVIDE SUPPLEMENTAL OXYGEN TO PATIENTS WITH COMPROMISED RESPIRATORY FUNCTION. IT IS NOT INTENDED NOR LABELED FOR USE AS A LIFE SUSTAINING DEVICE. IT WAS STATED BY THE REPORTER THAT THE PATIENT "PASSED OUT" (SYNCOPAL EPISODE) WHILE USING THE CONSERVER AND THAT THE CONSERVER WAS "BLOWING OUT ON ITS OWN" (AUTOPULSE). SYNCOPAL EPISODES ARE A TEMPORARY LOSS OF CONSCIOUSNESS AND POSTURE, DESCRIBED AS "FAINTING" OR "PASSING OUT". IT IS USUALLY RELATED TO TEMPORARY INSUFFICIENT BLOOD FLOW TO THE BRAIN. IT MOST OFTEN OCCURS WHEN THE BLOOD PRESSURE IS TOO LOW (HYPOTENSION) AND THE HEART DOES NOT PUMP A NORMAL SUPPLY OF OXYGEN TO THE BRAIN. SYNCOPE CAN BE CAUSED BY NEUROLOGICAL DISORDER, ORTHOSTATIC HYPOTENSION OR A SIDE EFFECT OF MEDICATIONS. AN ENGINEERING EVALUATION OF THE CONSERVER CONFIRMS THE INITIAL REPORTERS CLAIM THAT THE UNIT WAS AUTOPULSING. THE SETTING OF 2 L/MIN IS THE MOST COMMON PRESCRIPTION FOR HOME OXYGEN IN THE US AND THIS WAS CONFIRMED BY THE INITIAL REPORTER TO THE PATIENT'S PRESCRIPTION. AS NOTED IN THE FOLLOW-UP INTERVIEW OF THE INITIAL REPORTER, THE BONSAI WAS ON SETTING TWO (2) IN THE CONSERVE MODE, WHICH PRODUCES AN AVERAGE, UNIFORM BOLUS OF 22 ML OF OXYGEN PER CYCLE. THE UNIT WAS OBSERVED TO BE AUTOPULSING AT A RATE OF 140-150 BOLUSES/MINUTE, WHICH MEANS THE DEVICE WAS DELIVERING 140-150 TWENTY-TWO MILLILITER (22 ML) BOLUSES OF OXYGEN PER MINUTE. AS A RESULT, THE VOLUME OF OXYGEN THAT WOULD BE DELIVERED TO THE PATIENT VIA THE NASAL CANNULA PER MINUTE (MINUTE VOLUME) WOULD BE 3.08-3.3 LITERS OF OXYGEN (OR ESSENTIALLY 3.08-3.3 L/MIN). ALTHOUGH THIS BOLUS PATTERN IS INTERMITTENT AND ASYNCHRONOUS WITH THE PATIENT'S BREATHING PATTERN, THERE IS SIGNIFICANT OXYGEN FLOWING THROUGH THE DEVICE OVER THE COURSE OF EACH MINUTE, WHICH IS AVAILABLE FOR INHALATION. IN FACT, THE MINUTE VOLUME OF OXYGEN DELIVERED WOULD BE GREATER THAN THE AMOUNT DELIVERED BY A CONTINUOUS FLOW OXYGEN DEVICE AT THE 2 L/MIN SETTING. WITH THE INFORMATION PROVIDED, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A CAUSAL RELATIONSHIP BETWEEN THE UNIT AND THE PATIENT'S SYNCOPAL EPISODE. ALTHOUGH THE DEVICE WAS PERFORMING OUT OF SPECIFICATION, THE FAULT MODE RESULTED IN A RAPID, INTERMITTENT BUT NEAR CONTINUOUS FLOW (22 ML EVERY 400 MILLISECONDS) OF OXYGEN BEING DELIVERED TO THE PATIENT. BECAUSE THE UNIT WAS PROVIDING MORE THAN ENOUGH OXYGEN TO SATISFY THE PATIENT'S OXYGEN PRESCRIPTION, THERE IS NO EVIDENCE TO SUPPORT THE PATIENT'S TEMPORARY LOSS OF CONSCIOUSNESS (SYNCOPAL EPISODE) WAS CAUSED BY THE DEVICE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER CLAIMED THAT THE PATIENT CAME IN TO THE OFFICE FOR A VISIT AND WAS SEATED IN THE WAITING ROOM WITH THE UNIT ON. THE PATIENT SUDDENLY STARTED SLUMPING AND PASSED OUT. THE PARAMEDICS WERE THEN CALLED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. THE INITIAL REPORTER CLAIMED THAT THE UNIT WAS DEFECTIVE, BLOWING OUT CONTINUOUS ON ITS OWN. A FOLLOW-UP INTERVIEW WITH THE INITIAL REPORTER REVEALED THAT UNIT WAS SET TO THE PATIENT'S PRESCRIPTION OF 2 LITERS OF OXYGEN PER MINUTE ON CONSERVE MODE. HE ALSO EXPLAINED THE UNIT WAS ATTACHED TO A CYLINDER AND TESTED BY A SERVICE TECHNICIAN WHO DISCOVERED THE UNIT WAS BLOWING CONTINUOUSLY ON CONSERVE MODE. NO INFORMATION WAS AVAILABLE OR PROVIDED REGARDING THE PATIENT'S MEDICAL BACKGROUND NOR THE HOSPITAL DISPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685502 BONSAI OXYGEN CONSERVER OXYGEN CONSERVER NFB INOVO INC OM-812 16129 00814470020037

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization