MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAM STATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Lethargy (2560); Unspecified Respiratory Problem (4464); Dry Mouth (4485); Renal Impairment (4499); Solid Tumour (4552)

Event Type  Injury  

Event Description

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).

• Brand Name: DREAM STATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13237200
• MDR Text Key: 283845628
• Report Number: MW5106601
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/08/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White