MAUDE Adverse Event Report: RESMED CORP AIRSENSE 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DN331

Patient Problems Burning Sensation (2146); Choking (2464); Cough (4457)

Event Date 11/17/2023

Event Type  Injury  

Event Description

Cpap (continuous positive airway pressure) machine started smoking in the middle of the night.I woke up chocking on the smoke from the cpap.I coughed up the smoke out of my lungs.I had an extreme burning sensation in my lungs that lasted about two weeks.My pulmonologist had prescribed "albuterol" sulfate hfa inhalation aerosol (90mcg per actuation) but that didn't work.He has recently prescribed wixela (fluticasone propionate and salmeterol inhalation powder, usp) but that medication is also not working.Made in singapore.

• Brand Name: AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18552350
• MDR Text Key: 333517766
• Report Number: MW5150592
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DN331
• Device Catalogue Number: R390-447/1
• Device Lot Number: 1680634
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTERAL SULFATE HFA INHALATION AEROSOL (90MCG PER ACTUATION).; WIXELA (FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER, USP).
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American