MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMSTATION BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Inflammation (1932); Cancer (3262)

Event Date 04/01/2023

Event Type  Injury  

Event Description

I would like to add my information attesting to a possible connection between the use of the philips dreamstation bipap medical device and cancer.I've been a user of a philips respironics dreamstation bipap machine since 2018.I learned of the dreamstation recall in 2021 and registered for a replacement device.Ln about four months i received my replacement machine.However, in (b)(6) of 2023 i received a diagnosis of throat cancer (squamous cell carcinoma of the tonsillar tissue and six lymph nodes).The first symptom was noted by my primary care physician (pcp) in (b)(6) of 2023 and appeared as a slightly raised area immediately behind the right tonsil.Since i had undergone oral surgery a few weeks before, the pcp suggested we merely wait a few weeks & see how it progressed.Over the next 4 months it increased slightly in size & degree of redness.Then in late (b)(6), it suddenly burst & started bleeding.A subsequent examination by an oral surgeon resulted in a biopsy taken and a pet/cat scan administered, all of which confirmed the cancer diagnosis.I underwent 35 radiation treatments & 3 chemotherapy treatments.I'm currently in recovery mode and awaiting a pet/cat scan in (b)(6) to determine the outcome of the treatments.Whether there is a causal relation between the cancer & the use of the philips bipap machine is uncertain.I do have a family history of cancer via my mother & sister, both of which had breast cancer.However, i know of no other medical, biological or environmental factors that could have contributed to the cancer.I have never been a smoker or user of tobacco products, nor a heavy drinker.I've had no other serious medical condition except for atrial fibrillation for which i've undergone successful surgery to correct the problem.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18758842
• MDR Text Key: 336181884
• Report Number: MW5151810
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: B-COMPLEX. ; CALCIUM-MAGNESIUM.; GINGKO.; HERBAL SUPPLEMENTS.; HORSETAIL GRASS.; HYDROCHLOROTHIAZIDE.; IRON.; MULTI-VITAMIN.; NEXIUM.; OMEGA-3.; PYGEUM.; STILL USING REPLACEMENT BIPAP DEVICE.; TRANS-RESVERATROL.; VITAMIN C.; VITAMIN D.; VITAMIN E.; VITAMINS & MINERALS.; XARELTO.
• Patient Outcome(s): Life Threatening; Disability; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White