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

Device Problems Material Fragmentation (1261); Nonstandard Device (1420)

Patient Problem Aspiration/Inhalation (1725)

Event Date 05/15/2022

Event Type  malfunction  

Event Description

I purchased a resmed airsense 10 last year because my philips dreamstation 2 had been recalled for repair.Three (3) months ago, after a night's sleep, i was horrified to see that the resmed machine had "exploded" a lot of small dark green foam particles into the water reservoir and mask.I still don't know how much of it i breathed in.I called the supplier (cpap shop) and they had me send it back to them for "service".As of today i now have a total of 4 machines: 2 philips, 2 resmed that have been or are currently being repaired.Resmed is being very vague, i suppose hoping to stay under the radar, unlike philips who seemed to initiate their recall openly.No mention of any recall by resmed.Are you aware of this? in both cases i had been using a soclean ozone cleaning device regularly each day.That product is still on the market as are the adapters for both brands, sold by the same supplier from whom i bought the caps.Is there no standard for this stuff, or official (fda?) oversight? fda safety report id # (b)(4).

• Brand Name: RESMED AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15258594
• MDR Text Key: 298436610
• Report Number: MW5111595
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 08/17/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White