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

Model Number DSX500H11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemoptysis (1887); Cancer (3262)

Event Date 12/08/2022

Event Type  Injury  

Event Description

Developed a cough and started coughing up blood.Had ct scan, met scan, bronchoscopy, brain scan, and it was determined that i have stage 2 non small cell lung cancer.The cancer type is adenocarcinoma.Currently undergoing radiation and chemotherapy treatment until mid may.Surgery to remove all or part of the lung in early june.Hypermetabolic mass in the perihilar aspect of the right lower lobe is in keeping with presumed lung cancer.No mediastinal adenopathy or distant metastasis.

• Brand Name: DREAMSTATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16690089
• MDR Text Key: 312869692
• Report Number: MW5116386
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BISOPROLOL; DAILY VITAMINS ; FLOMAX; LIPITOR; OMEPRAZOLE; USING RESMED CPAP
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White