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

Lot Number 1687152

Device Problems Device Emits Odor (1425); Structural Problem (2506)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/02/2023

Event Type  Injury  

Event Description

On june 2, 2023 i received a resmed airsense 11 cpap (continuous positive airway pressure) machine to replace my existing resmed airsense 10 cpap machine because the airsense 10 machine was emitting fumes which made it impossible to use.However, the new airsense 11 machine was actually emitting even worse fumes and is unusable by me.This has been a continuing problem with cpap machines made of plastic (which they all are).When the heating element heats the water in the water reservoirs (to provide humidity), it also heats the adjacent plastic in the reservoir, emitting fumes.L seem to be particularly sensitive to these fumes, and i suspect that, over time, they are probably not good for anyone using these machines.Because of this defective design in the machines, they all tend to fail in a fairly short time, requiring new machines at intervals that are much shorter than would be required of machines made by stainless steel (or some other metal other than plastic).L suspect that continuing to make the machines out of plastic could well be a "planned obsolescence" so that the manufacturers can replace them after fairly short usage.I have spoken both with my sleep study doctors and with the manufacturer of the machine to express my misgivings about the machine, but there is considerable resistance to change.I suspect that, over time, being continuously exposed to the plastic fumes emitted by these machines must be harmful to the many people who must use these cpap machines.A better alternative is required! i am not aware of any tests that have been done to show whether plastic use in cpap machines has harmful effects over time, but clearly, being exposed to the plastic fumes every night for years is likely to have adverse effects on users.Reference report: mw5118860.

• Brand Name: RESMED AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY. LTD.
• MDR Report Key: 17217044
• MDR Text Key: 318138691
• Report Number: MW5118859
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1687152
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN.; CETIRIZINE HYDROCHLORIDE FOR ALLERGIES.; CPAP MACHINE NOT BEING USED DUE TO FUMES. ; FINASTERIDE.; MAGNESIUM.; MULTI VITAMINS FOR 55+ MEN. ; VITAMIN D.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White