MAUDE Adverse Event Report: OMRON BIPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Hemorrhage/Bleeding (1888); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)

Event Date 11/29/2023

Event Type  Injury  

Event Description

I had used azelaic acid gel 15% for several years.It didn't seem to be working well on my red face.My dermatologist recommended rhofade cream 1%.My pcp (primary care physician) agreed and my insurance agreed to pay.I started rhofade on (b)(6) 2023.It didn't seem to help my red face, but i decided to give it time.Besides my red cheeks, i developed sores on my cheeks.I also noticed that the bipap (omron) i use for severe sleep apnea was leaking more and that affected my sleep.On (b)(6) 2023 one of my sores started bleeding.So on (b)(6) 2023 i went back to using azelaic acid.Looking at my bipap leakage over the 16 days i used rhofade my leakage reached 32.4-91.2 l/min for 10 of the days.When i switched back to azelaic acid my leakage has not gone above 8.4 l/min.No adjustment required.It was 0 l/min the first night after using it.

• Brand Name: OMRON BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• MDR Report Key: 18411322
• MDR Text Key: 331640465
• Report Number: MW5149655
• 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: 12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White