MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. REMSTAR AUTO SYSTEM ONE 60 SERIES CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Cancer (3262); Nodule (4551)

Event Date 07/31/2023

Event Type  Injury  

Event Description

(b)(6) 2018 - had a chest x-ray that stated, "the lungs were clear" and "normal examination¿.(b)(6) 2020 ¿ i began using a philips remstar system one cpap (sn# (b)(6)).Machine was purchased by my late husband on (b)(6) 2013.He used it only 8 times during the spring of 2013.In late (b)(6) 2020 i was in need of a cpap machine as insurance had reclaimed my initial machine.My (b)(6) sleep neurologist arranged to have the settings on the philips system one machine adjusted for me and i began using it.I used the philips system one machine from (b)(6) 2020 until (b)(6) 2021 (545 nights; average = 4 hrs; 28 mins/night).For approximately the last 6 months of my use, black particles were collecting in the humidifier chamber that i had to clean out.Just under 2 yrs after i finished using the philips remstar machine ((b)(6) 2024) an abdominal ct scan discovered a >1cm lobulated nodule in my lower right lung.Follow-up with other scans a 2nd chest ct on (b)(6) 2024, noted the lobulated nodule to be mostly solid & to have grown to 1.6cm.Nodule was biopsied on (b)(6) at (b)(6) and found to be cancerous (adenocarcinoma).Scheduled for surgery at (b)(6) shortly for lung cancer.In summary - 2018 chest x-ray shows no problems.About 1 ½ yrs.Later began using a philips cpap machine (used for 1 ½ years).Last ½ year of that time i see visible black particles in the humidifier chamber.Just under 2 yrs.After discontinue use, >1cm cancerous nodule found in lung of 57 y.O.Woman who never smoked.I registered with philips in (b)(6) 2021.In fall 2022, philips initiated an "opt in" process for system one users.I found out about this accidentally; i was not notified by philips.After opting in, i was notified in the portal that i needed to submit a cpap prescription from my provider to continue the replacement process.I obtained one but there was no mechanism in the portal to submit it.When i called philips on (b)(6) 2022 asking how to submit it, i was informed that they weren't taking info from system one users then¿ only dream stations.When asked when they would, i was told someone from philips would call me back.No one called me back then or on other occasions when tried to submit.In spring 2023 philips wanted access to doctor, vs.Prescription, but was able to argue to get them to take prescription (but had to argue for it).In (b)(6) 2023, 2 yrs after registering, a "replacement" machine was shipped to me ¿ ironically about a week after cancerous nodule was 1st found in my lung.Box contained letter and smaller sealed box with a "refurbished" dream station machine.I never opened the sealed box with the dream station because after reading the letter i wrote a reply and shipped it all right back to philips.Did so because letter stated, "before starting or resuming therapy on your new or replacement machine, visually inspect the following accessories for evidence of black foam particles or any particulate contamination on tubing, mask components (mask, cushions, and integrated tubing), [and] humidifier¿.Philips had sent me someone else's used machine with the same potentially degrading black foam problem and was placing the burden on me to assess for foam's presence.Philips has not acknowledged that i returned the dream station they sent me.I still have the system one machine i used from (b)(6) 2020 - (b)(6) 2021.Biopsy done at (b)(6) on (b)(6) 2024 - adenocarcinoma of the lung.For additional information please see picture of device.The picture i included was the one of the bottom labels of the cpap machine.Reference report: mw5152117.

• Brand Name: REMSTAR AUTO SYSTEM ONE 60 SERIES CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18806863
• MDR Text Key: 336749559
• Report Number: MW5152116
• 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: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White