MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAM STATION -1. CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Memory Loss/Impairment (1958); Fibrosis (3167); Cancer (3262); Cough (4457)

Event Date 12/01/2020

Event Type  Injury  

Event Description

Developed chronic cough since then.Recurrent laryngoscopies demonstrated laryngopharyngeal inflammation and upper respiratory inflammation -developed uterine bleeding in 2021 and diagnosed with uterine cancer, underwent, surgery and radiation - developing unexplained progressive memory loss.Multiple in cf(cystic fibrosis) investigation done including ct, pet scans, blood tests and biopsies.

• Brand Name: PHILIPS DREAM STATION -1. CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18780331
• MDR Text Key: 336318501
• Report Number: MW5151941
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian