BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURIFY O3 CPAP

    MDR report key: 15605965 · Received October 13, 2022

    Report

    Report Number
    MW5112625
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    February 8, 2020
    Report Date
    October 11, 2022
    Manufacturer
    RESPONSIVE RESPIRATORY INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE RESPIRONICS DSX500HIIC AND DREAMSTATION AUTO CPAP (B)(4) W/ RESPIRONICS DSXH DREAMSTATION HUMIDIFIER (B)(4) BEGINNING ON (B)(6) 2020. I PURCHASED A PURIFY O3 CPAP/BIPAP SANITIZER VENTILATION DISINFECTOR MODEL #190-6000 PURIFY O3 SANITIZER , XD100 SN# (B)(4) ALL MEDICAL EQUIPMENT WAS MADE IN CHINA. I AM NOT SURE OF THE EXACT DATE BUT BEGAN HAVING DEEP-BREATHING DIFFICULTIES ON A WEDNESDAY NIGHT. IT WAS HARD TO BREATH, PAINFUL, AND I WAS EXHAUSTED. I DISCUSSED THIS WITH THE TIDEWAY AQUATIC THERAPY SUPERVISOR ON THURSDAY. I WAS ADVISED TO GET A CHEST X-RAY FOR PLEURISY OR PNEUMONIA. I HELD OFF, BUT ON SATURDAY I WOKE UP WORSE. TAKING DEEP BREATHS WAS PAINFUL, BURNING, AND I DEVELOPED A FEVER WITH HEAVY SWEATING AND WAS WEAK. MY ROOMMATE TOOK ME TO (B)(6). DR (B)(6) DIAGNOSED PNEUMONIA BUT SAID SHE HAD NOT SEEN THE LIGHT-COLORED COLLECTION OF FLUID IN LUNGS BEFORE. I WAS GIVEN A PRESCRIPTION FOR CEPHALEXIN 500 MG CAPS LUPI AND TOLD TO NOT SKIP A DOSE. SHE ALSO TOLD ME TO SCHEDULE A FOLLOW-UP WITH DR (B)(6) (PCP) IN TWO WEEKS. THE PRIMARY PAIN WAS BURNING IN MY THROAT AND NOSE WITH BREATHING DIFFICULT. IT WAS SHORTLY AFTER THAT CPAP MACHINES WERE RECALLED BUT NOTHING WAS SAID ABOUT THE PURIFY O3 DEVICE. I HAVE GONE WITHOUT A CPAP MACHINE ALL THIS TIME AND NEED TO GET ONE ASAP. THANK YOU FOR THE OPPORTUNITY TO SHARE THIS MEDICAL INFORMATION. IF FURTHER INFORMATION IS NECESSARY, PLEASE LET ME KNOW. (B)(6). I HAVE A COMPLETE REPORT WITH DATA FOR MANY CATEGORIES. I DO NOT KNOW HOW TO GIVE: TITRATION SUMMARY, PES SUMMARY, OXYGEN SATURATION SUMMARY, ECG SUMMARY, HEARTATE DETAILS, RHYTHYM DETAILS, AROUSAL SUMMARY, OR LIMB MOVEMENT SUMMARY DUE TO THE DETAIL IN EACH CATEGORY. THERE WAS ALSO A PAGE WITH HYPOPNEA CRITERIA, SUMMARY STATEMENTS, PARAMETERS, AND SCORING INFORMATION. THE STUDY CONSISTED OF THE PARAMETERS AND OVERNIGHT RECORDINGS OF CONTINUOUS EKG WAVEFORM, CONTINUOUS AIRFLOW ASSESSMENT, MONITORING OF RESPIRATORY EFFORT, CONTINUOUS OVERNIGHT OXIMETRY WITH A SAMPLING RATE OF 10 SAMPLES / SECOND, AND VIDEO RECORDING. (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241331 PURIFY O3 CPAP DISINFECTANT, MEDICAL DEVICES LRJ RESPONSIVE RESPIRATORY INC. 190-6000 O3 SANITIZER
    2241332 RESPIRONICS DSX500HIIC VENTILATOR, NON-CONTINUOUS (RESPIRATOR) LRJ RESPIRONICS, INC. DSX500HIIC
    2241333 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) LRJ RESPIRONICS, INC. J26922418C833, H26021415ADE1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other| R ANTACID CONTROL| ANTI-DEPRESSANT| APPLE CIDAR VINEGAR| ARMODAFINIL TAB 50 MG| ATORVASTATIN TAB 20 MG| BENEFIBER WAFERS| CEPHALEXIN 500 MG X4 PRE-MED| CLONAZEPAM TAB 0.5 MG 2X/DAY (STOPPED UNTIL I CAN GET BACK ON CPAP, HAVE CORRECTIVE SURGERY, OR INSPIRE PROGRAM)| CLOPIDOGREL BISULFATE TAB 75 MG| DIURETIC| FISH OIL| LIPITOR| LOW-DOSE ASPIRIN| MECLIZINE HCL TAB 12.5 MG 1 TAB 3X / DAY AS NEEDED| NUVIGIL 50 MG| OMEPRAZOLE DR CAPSULES 20 MG X 3| OZEMPIC 1.5 INJECTION| PRE-MED BEFORE DENTAL AND ANY SURGERIES. | TAKE PLAVIX| TRAZODONE HCI ZYDU 100 MG| TRIAMTERENE HCTZ CAP 37.5/25 MG| TURMERIC| VITAMIN B-D-C