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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Health issue; ozone ruined my cpap machine.After two years i found foam particles in my resmed 10 cpap water chamber.Soclean 2 ozone machine was used.Fda safety report id # (b)(4).

• Brand Name: AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 14136992
• MDR Text Key: 289663666
• Report Number: MW5109078
• 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: 04/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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 Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male