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

Device Problem Use of Device Problem (1670)

Patient Problems Atrial Fibrillation (1729); Biliary Cirrhosis (1736); High Blood Pressure/ Hypertension (1908); Weight Changes (2607); Cancer (3262); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/03/2021

Event Type  Injury  

Event Description

Began using philips cpap in 2018.Diagnosed with lung cancer (b)(6) 2021.Hypertension, obesity; a-fib, congestive heart failure, liver cirrhosis / cancer.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17172742
• MDR Text Key: 317645980
• Report Number: MW5118491
• 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: Other
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: ALBUTEROL SULFATE ; BUMETANIDE ; DILTIAZEM ; FEROSUL ; LEXAPRO ; MECLIZINE ; OMEPRAZOLE MAGNESIUM ; POTASSIUM CHLORIDE ; SPIRONOLACTONE ; SUCRALFATE ; TRAZODONE
• Patient Outcome(s): Disability; Other; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White