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

Model Number 10

Device Problem Material Fragmentation (1261)

Patient Problem Aspiration/Inhalation (1725)

Event Date 03/06/2022

Event Type  malfunction  

Event Description

I wanted to notify the fda of a major issue with use of so clean and resmed.On sunday, march 6, i found lots of greenish specks in my resmed 10 water chamber.I thought at first it was mold, so i looked at everything, rewashed tubing, mask, etc.And could not find it.I changed the water out and started the resmed and checked the water, and again the specks were in it.I did this a couple of times.I went through all of my paperwork and trouble shooting and no where did it mention what to do if you found specks in your water that came from the blower area.However, i did find that on page 16 of the manual it said that damage caused by ozone would not be covered by the limited warranty.I use a so clean on my resmed machine, which uses ozone.I did some research online and found that ozone could damage a filter/foam piece on the inside of the machine.Since the warranty was probably voided, i watched videos on how to open the machine.I opened up the machine, and the filter/foam was gone from where it should have been.I went further into the machine, and the motor/blower case had filter/foam in it.Ninety-nine (99%) of the filter/foam or more was gone.There were still pieces in it.I tried to blow out most of it with my mouth by blowing into that area, which blew out a lot of what was in there.I then took an air pump that blew air and used it to push more of the filter out.I believe i got most of it out.I then reconnected the machine, and it works fine.However, i need my sleep apnea machine, as i have severe osa and stop breathing on average 42 times over the course of an hour.I still see some specks in my water but not like i did on march 6th.I breathed in this disintegrated filter for over a year and have concerns on what it may have done or what it could do in the future to not only me but others as well.As you are not supposed to open the machine, this means that many consumers may not even know that this has happened to them also.Fda safety report id # (b)(4).

• Brand Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Type of Device: RESMED AIRSENSE 10
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 13976960
• MDR Text Key: 288620716
• Report Number: MW5108710
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00619498370900
• UDI-Public: (01)00619498370900
• 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: 03/30/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10
• Device Catalogue Number: RESMED AIR SENSE 10
• Device Lot Number: 1471729
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LISINOPRIL 10 MG TABLET; 50 MCG (2,000 UNIT) CAPSULE ; ARNUITY ELLIPTA 200 MCG/ACTUATION INHALER ; ATORVASTATIN 10 MG TABLET; CETIRIZINE 10 MG CAPSULE ; CHOLECALCIFEROL; FLUTICASONE PROPIONATE 50 MCG/SPRAY SPRAY; MULTI VITAMIN; SUSPENSION NASAL INHALER ; VITAMIN D3
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White