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

Model Number 37207

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2018

Event Type  malfunction  

Event Description

While using my resmed airsense 10 autoset cpap at around 3 in the morning.I woke secondary to a loud noise from the machine's impeller rubbing.It lasted perhaps 15 seconds after i awoke.The next morning, i dumped the water from the humidifier chamber into the sink.I noticed a large amount of a dark material washing down the drain.The next morning, i carefully looked at the water and more material was in the water.I scooped some of the particles with the water and placed the water in a sealed plastic container.I then placed a so called "bacterial" filter inline between the machine and my mask (commercially available for use on cpap/bipap hoses so as to prevent any of these particles from making it into my lungs.I do not have current serious symptoms but i worry that some of the particles may have made their way into my lungs as the aforementioned filter has trapped particles (the larger particles appear to be caught by the water in the humidifier chamber, thank god).I kept using the machine until this morning because i had to wait until today for an appt that fit my schedule.There are three or so large particles in the filter but it looks darker than when new, so there could have been finer particles in the air stream.I have retained some of the particles as well as the inline filter mentioned above.Before i turned it in this morning, i took a picture of what i thought was a label that included the serial number, unfortunately i don't see it.I turned it into (b)(6).They should have the serial number, i requested them to also fill out a report to you.Ps: your mobile app would not go past the search page, so it is totally useless and until fixed consideration should be made to stop sending people that way.Device: iphone.

• Brand Name: AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD.
• MDR Report Key: 8019419
• MDR Text Key: 125757629
• Report Number: MW5080927
• 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: 10/25/2018

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
• Device Model Number: 37207
• Device Catalogue Number: 37207
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 113