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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2021

Event Type  Injury  

Event Description

I have had barrett's esophagus for approximately 6 years, and recently i had another scraping of my esophagus.I was unable to eat, drink, and was having trouble swallowing, and my voice changed where i could not be understood with what i was trying to say, so i went to the er and they did the scraping where not only polyps were attached to my esophagus.They were also attached to my adenoids and came back malignant on (b)(6) 2022, spent 4 days in the hospital.I used my cpap on a regular basis.I'm thinking the problem might have been caused by dreamscapes cpap machine.Philips should be on the bottom.Fda safety report id# (b)(4).

• Brand Name: DREAM STATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15720414
• MDR Text Key: 303077022
• Report Number: MW5113057
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Patient Sequence Number: 1
• Treatment: FISH OIL; AUSTEDO 15 MG TWICE DAILY; BENZTROPINE 1MG TWICE A DAY; CALCIUM; CARVEDILOL 3.12 2X DAILY; DICYCLOMINE 20MG 3X DAILY ; GABAPENTIN 600MG 2 TABS TWICE DAILY; HYDROXOXYCHLOROQUINE 200MG 2X DAILY; INGRREZZA 60MG DAILY; IRON SUPPLEMENT; KLONOPIN2MG 2X DAILY; LATUDE 60MG DAILY; MIDODRINE 2.5 3X DAILY; NIFEDIPINE 10MG 3TIMES DAILY; OMEPRAZOLE 20MG TWICE DAILY; ONE ADAY; PRAVASTATIN 40MG DAILY; PRAZOSIN 1MG 3X DAILY; ROPINIROLE .5 AT BEDTIME; VENLAFAXINE 75MG DAILY; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White