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

Patient Problems Sensitivity of Teeth (2427); Sleep Dysfunction (2517); Dry Mouth (4485)

Event Type  malfunction  

Event Description

Resmed specifies that their airsense 11 has a 380 ml humid tank but it only holds 325 ml as measured with a 500 ml graduated cylinder.This machine's tank lasted only 6 hours from the day i received it to replace a recalled philips.The philips did not dry out in the 5 years i had it.One, i created a straw poll on a facebook resmed group of over 100 people and 17% report running out of water.Two, my doctor also tells me other people have reported running out of water.I tried asking for another machine and doctor tells me i likely can't get one because i haven't had it 5 years yet.My doctor lowered the cpap (continue positive airway pressure) pressure which made the tank last 7.25 hours rather than 6 but i still am woken up by burning smell and dry mouth if i don't happen to wake up before the tank dries out.Sometimes my teeth hurt and the roof of my mouth feels burnt from being dried out.On my last call to resmed to find out if an optional larger tank is forthcoming, the customer rep seemed annoyed with me stating that i had reported this 2 times before.I don't think contacting resmed 3 times in a year is excessive.I asked if there were any plans for an optional larger tank and she replied that all she can do is forward my comments to the appropriate people.In other words, she would not find out for me.If resmed does not come out with an optional larger tank for the resmed 11 they should at minimum correct their product specifications where 380 ml capacity is claimed.(note: i also measured my sister's older resmed 10 capacity which is likewise specified as 380 ml but only holds 350 ml).

• Brand Name: RESMED 11 AIRSENSE AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 19128160
• MDR Text Key: 340589776
• Report Number: MW5153938
• 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: 04/13/2024

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: 04/16/2024
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL.; APIXABAN.; AZILECT.; CELECOXIB.; CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE).; FENOFIBRATE. ; LISINOPRIL.; METFORMIN. ; METOPROLOL.; MONTELUKAST.; SIMVASTATIN.; SINEMET. ; VITAMIN D3.
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White