MAUDE Adverse Event Report: RESMED CORP CPAP MASK AIRFIT 20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Dizziness (2194); Discomfort (2330)

Event Date 01/01/2023

Event Type  Injury  

Event Description

I am experiencing extreme lightheadedness.At times its overwhelming.I have repeatedly reported to my physician.I cannot have an mri because of my cochlear implant so i have been suffering with this on a daily basis.This magnet may be causing my discomfort.I have been wearing this equipment for 5 years and only the past several months i have experienced this constant lightheadedness and overwhelming sensation.I cannot have a mri because of my implant.

• Brand Name: CPAP MASK AIRFIT 20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18589496
• MDR Text Key: 333957571
• Report Number: MW5150775
• 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: 01/23/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Patient Sequence Number: 1
• Treatment: BREO ELLIPTA.; MOUNJARO. ; MULTIVITAMIN.; RESMED CPAP MACHINE.
• Patient Outcome(s): Disability; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American