BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO

    MDR report key: 13237200 · Received January 11, 2022

    Report

    Report Number
    MW5106601
    Event Type
    Injury
    Date Received
    January 11, 2022
    Report Date
    January 8, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    MNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED PHILIPS / RESPIRONICS AUTO CPAPS FOR 20+ YEARS. REMSTAR AUTO, SYSTEM ONE AUTO AND DREAM STATION AUTO. DOCUMENTED MEDICAL CONDITIONS: I HAVE GROWTHS IN MY LUNGS BI-LATERAL. I AM IN O2 AT 3LPM 24/7 WITH BLEED IN TO COAP. I HAVE SEVERELY DECREASED GFR LEVELS THAT HAVE DECLINED SIGNIFICANTLY IN THE PAST 2 YEARS. A MASS HAS BEEN FOUND IN MY LIVER, LEFT ADRENAL GLAND AND ALSO I HAVE IN THE LAST YEAR BEEN DIAGNOSED WITH A CAROTID BODY TUMOR, MULTIPLE THYROID TUMORS, AND RECENTLY 2 LYMPH NODES THAT MAY BE "REACTIVE". I AM ALSO HAVING ORAL ISSUES AND WAKING UP WITH A VERY DRY MOUTH FOR THE PAST 2 YEARS, USING THE DREAM STATION. MY ENERGY LEVELS HAVE GONE DOWN CONSIDERABLY. PLEASE FEEL FREE TO CONTACT ME FOR ANY QUESTIONS AND MORE DETAILED INFORMATION. UNKNOWN REASON FOR GLOMERULAR FUNCTIONS DRASTIC DECREASE IN THE PAST FEW YEARS. DIABETES A1C HIGHEST HAS BEEN 7.1 - 7.2 RECENT TESTING ON (B)(6) 2021 SHOWS A1C AT 6.1, DIABETES IS BEING WELL MANAGED. CREATINE/BUN LEVELS ONLY SLIGHTLY ELEVATED. SHIPPING NUMBER FOR RETURN OF CORRUPTED DREAM STATION TO PHILIPS, IS INCLUDED IN IMAGES. I HAVE MY OLD CPAPS, I WILL NEED TO FIND THEM IN STORAGE. DOCUMENTED DIAGNOSES: INTERSTITIAL LUNG DISEASE (RESTRICTIVE) DIABETES MELLITUS II HYPERTENSIVE DISORDER ??DO NOT ADMINISTER IMAGING CONTRAST)?? ACQUIRED POLYCYSTIC KIDNEY DISEASE (GFR AT 53 (B)(6) 2021 / 43 (B)(6) 2021) URINARY INCONTINENCE BILATERAL HIP JOINT PAIN BILATERAL KNEE PAIN CHRONIC SECONDARY DYSTHYMIA EDEMA OBESITY (B)(6) OSTEOARTHRITIS OBSTRUCTIVE SLEEP APNEA SYNDROME INSOMNIA PERMANENT DISABILITY CHRONIC LOW BACK PAIN ANXIETY MULTI NODULAR GOITER BI-LATERAL REVIEWED (B)(6) 2021 CAROTID BODY TUMOR (R CAROTID BIFURCATION) REVIEWED (B)(6) 2021 L ADRENAL MASS IN CT HEPATIC MASS IN CT PANCREATIC ATROPHY LYMPH NODES - 2 LEFT SIDE NECK REACTIVE IN MRI (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902202 REMSTAR AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) MNS PHILIPS / RESPIRONICS, INC.
    1902203 SYSTEM ONE AUTO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS / RESPIRONICS, INC.
    1902204 DREAM STATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) MNS PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability CHLORTHALIDONE 50MG TABLET. QD | CPAP Q HS AUTO CPAP AT 9MM/HG-20MM/HG Q HS | FISH OIL 2000MG/ OMEG3 600MG QD | GLIPIZIDE 5MG Q AM | LISINOPRIL 40 MG TABLET QD | METFORMIN 1,000 MG TABLET BID| MULTIVITAMIN W/ FOLIC ACID - PRENATAL QD | OXYGEN CONCENTRATORS AUTO CPAP MEDICATIONS O2 AT 2LPM. | TIZANIDINE 4 MG TABLET PRN TAKE 1 TABLET EVERY 6 HOURS BY ORAL ROUTE AS NEEDED FOR MUSCLE SPASMS | VENTOLIN HFA 90 MCG/ACTUATION AEROSOL INHALER - INHALE 2 PUFFS EVERY 4 HOURS BY INHALATION ROUTE. PRN| VIT C 1000 W/ COQ10. Q.O.D | VIT D3 - 5000 I.U. QD