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

Device Problem Use of Device Problem (1670)

Patient Problems Respiratory Tract Infection (2420); Cancer (3262)

Event Type  Injury  

Event Description

Began using philips cpap in 2018.Began having chronic sinus infections in 2018.Diagnosed with lung cancer (b)(6) 2021.Refer to additional documents in i2k.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17218502
• MDR Text Key: 318137332
• Report Number: MW5118879
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Treatment: DUTASTERIDE; LOSARTAN; TAGRISSO; TAMSULOSIN
• Patient Outcome(s): Disability; Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White