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

Device Problem Device Emits Odor (1425)

Patient Problem Aspiration/Inhalation (1725)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

I received a new cpap resmed airsense 11 machine.When using the machine, it is giving off a very strong solvent smell which is not coming from the humidifier, tubing, or mask.I have only cleaned the machine with water.I contacted the distributor and resmed both.Neither representative claims any previous knowledge of this problem occurring with other patients.I have been using the machine and although the smell has decreased, it still exists and it has been 2 months.I am concerned that this chemical smell might be either carcinogenic or might kill brain cells.I think it is unlikely i am the only person that is having this problem.Checking the internet, i have found other similar complaints.I am positive most people this is happening to do not know to contact the fda.Further, when i contacted my distributor, they said to contact resmed.When i contacted resmed, they said to contact my distributor.I asked if resmed would file a report to the fda and was told that they would contact their quality department, and did not want to know who i am.Fda safety report id # (b)(4).

• Brand Name: AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15562761
• MDR Text Key: 301556290
• Report Number: MW5112487
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Patient Sequence Number: 1
• Treatment: ALBUTEROL INHALER; INSULIN; METOPROLOL; QVAR
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White