MAUDE Adverse Event Report: RESMED CORP. AIRSENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 37160

Patient Problems Aspiration/Inhalation (1725); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 10/07/2023

Event Type  Injury  

Event Description

Problem with resmed airsense 10.Hello fda, i am writing you because i have had an adverse reaction to using my new airsense 10 machine made by resmed and would like your help.I have used a cpap (continuous positive airway pressure) machine for approximately 15 years.Most recently my old resmed airsense 10 machine started showing a display that said "motor life exceeded please contact your provider" (i have been using that machine for approximately 7 years and the machine has functioned well.) i think it is important to mention that i am a retired intensive care nurse so have had some experience with medical devices.Approximately 2 weeks ago i picked up a new resmed airsense 10 and started using it.I washed out all the new tubing and mask before using it.Within the first few minutes of using the machine i felt a "dryness" in my chest and i started coughing and continued coughing.It was a 1 to 1 correlation.There was also a sweet smell coming through the machine.I got out of bed and removed the mask and tubing and replaced it with the old mask/tubing i had been using.I also wiped out the inside of my new machine.This did not totally resolve the problem and so after several days i replaced the water chamber with an old type of water chamber which has a totally metal bottom (base).This definitely was an improvement but i still have a dryness and uncomfortable feeling in the back of my throat but am not coughing.I did not have this problem with my old airsense 10.Bottom line: i believe the plastics in the machine or water chamber are giving off a gas or microparticles that are irritating my airway.Would you please have someone test a new airsense 10? there are so many people using these machines.Thank you, (b)(6).Reference report: mw5147820.

• Brand Name: AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18083352
• MDR Text Key: 327865265
• Report Number: MW5147819
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 37160
• Device Lot Number: 1722298
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN.; JANUMET. ; PAPAYA.; VITAMIN C. ; VITAMIN D.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White