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

Model Number DS2ADV AUTO CPAP W/HUMID+HT

Patient Problems Breast Cancer (1759); Lymphoma (3263); Unspecified Respiratory Problem (4464); Solid Tumour (4552)

Event Date 01/08/2024

Event Type  Injury  

Event Description

I presented to my primary care doctor in (b)(6) with a lump on the far left of my left breast which, at the time, was thought to be a fatty cyst or some other benign bump.My pcp ordered an us to be prudent.The us report indicated "moderately suspicious for malignancy." at the time i was, and still remain, asymptomatic.I had a biopsy of the mass on my left breast and an enlarged lymph node in my left axilla on (b)(6) 2024 which came back positive for invasive ductal carcinoma.This was followed up with a ct scan and then a pet scan between (b)(6).I have seen two oncologist during this time frame and am awaiting a lung biopsy.The current opinion of both oncologists is that i most likely have two separate but cooccurring cancers; stage 2a breast cancer and stage 3 lung cancer, which the lung biopsy will verify.There is also, of course, the possibility that i have stage 4 breast cancer.I am not certain that the use of the recalled philips cpap is a culprit in my predicament, but i also cannot rule it out.It is certainly unusual, according the oncologists i have seen, to have two primary cancer tumors at the same time; i am only 59 years old and otherwise in general good health.Nodule in upper left lung "more suspicious for primary lung cancer" though "metastatic disease from the breast is also possible.".

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18622444
• MDR Text Key: 334402772
• Report Number: MW5150941
• 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: 01/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS2ADV AUTO CPAP W/HUMID+HT
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN ; ATORVASTATIN; DOXYLAMINE; GABAPENTIN; IBUPROFEN ; VORTIOXETINE
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native