MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. CPAP - REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number REV 01

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problems Cancer (3262); Renal Impairment (4499)

Event Date 01/21/2021

Event Type  Injury  

Event Description

Lung cancer, kidney disease.Copies of any / all tests will be sent upon request.In 2011 - had emergency surgery in (b)(6) while on vacation.Anesthesiologist stated i had severe case of apnea and should have a sleep study done when i returned to (b)(6).I had sleep study at (b)(6) hospital.I was referred to a pulmonologist affiliated with (b)(6).My current pulmonologist is dr.(b)(6).Was issued a philips respironics cpap machine sn: (b)(4).I used the cpap daily at bedtime.In 2018, i had a broken humidifier water chamber.When i went to the (b)(6) i was informed the chamber was outdated as was the machine.I was then told to contact my pulmonologist to order a new machine since the one i was using was seven years old.I was issued a new philips resmed cpap machine sn: (b)(4).I use the cpap daily.On (b)(6) 2020 saw my pcp, dr.(b)(6), for a wellness check.When asked about the pulmonary nodules, i stated i would discuss the pulmonary nodules with the pulmonologist in (b)(6) 2020 for my annual cpap appt.Due to covid-19, in person appts were canceled.On (b)(6) 2020, i had a phone appt with (b)(6) aprn regarding my cpap.I asked about the pulmonary nodules and what should be done.I was told to wait until the end of the year and f/u testing would be done.On (b)(6) 2020 - saw pulmonologist, dr.(b)(6).I was told everything was stable and he was 98% sure it was not cancer, but the only way to be positive was to have a biopsy.My husband and i decided to have the biopsy.On (b)(6) 2021 - met with dr.(b)(6), oncologist to discuss radiation treatments of the biopsy site.Dates were set up for initial mapping and three high dose, short blast radiation treatments at the (b)(6).(b)(6) 2021, 3/l (b)(6) 2021, and (b)(6) 2021.On (b)(6) 2021 - received a certified letter from philips respironics regarding the recall of cpap machines.I called to register my cpap.My confirmation code is: (b)(4).The information sent stated the potential risks of particulate exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.G.Kidneys and liver) and toxic carcinogenic affects.On (b)(6) 2021- sent a letter with enclosures to dr.(b)(6) requesting her view of any correlation of the biopsy findings and the cpap recall.Have not received any answer.Because of the cpap recall, do i also have more severe kidney damage issues in my future? kidney dialysis? kidney transplant? anti-rejection drugs? will i have more lung biopsies? more radiation? whatever the outcome, i know my quality of life and my quantity of life has been compromised.I will be dealing with these issues for as long as i live.

• Brand Name: CPAP - REMSTAR PRO C-FLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12804217
• MDR Text Key: 280910961
• Report Number: MW5105277
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REV 01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BAYER LOW DOSE ASPIRIN 81 MG; BETAMETHASONE DIPROPIONATE 0.05% CREAM ; CALCIUM 500 MG. DIETARY SUPPLEMENT; CRESTOR CALCIUM 20 MG. (CHOLESTEROL) ; FISH OIL 1200 MG. DIETARY SUPPLEMENT; GUAIFENESIN 200 MG (SINUS); HYDROCODON-ACETAMINOP HN 10-325 (NORCO) (BACK PAIN); ISOSORBIDE MN ER 30 MG (IMDUR); LATANOPROST OPTH. SOLUTION 2.5 ML. (EYES); LISINOPRIL 5 MG (HEART-BP) (PRINIVIL); METHOCARBAMOL 500 MG. (MUSCLE SPASMS) (ROBAXIN); METOPROLOL SUCC ER 25 MG. (HEART-BP)(TOPROL-XL); MULTI VITAMIN DIETARY SUPPLEMENT; NABUMETONE 500 MG, (ARTHRITIS) (RELAFEN); OMEPRAZOLE 20 MG (HEART BURN); VITAMIN D 1000 IU DIETARY SUPPLEMENT
• Patient Outcome(s): Disability; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White