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

Lot Number 1417685

Device Problem Particulates (1451)

Patient Problem Cough (4457)

Event Date 12/25/2022

Event Type  Injury  

Event Description

Cpap resmed airsense 10 - noticed green particulate matter in my cpap humidifier reservoir.Upon removing the humidifier reservoir, foam pieces were freely blowing out of the machine.After a few nights of continuing to notice foam particulate matter in the humidifier reservoir, i disassembled the cpap and found disintegrated balled up foam adjacent to the blower.I have been experiencing a dry hacking cough past 6 months which has worsened.

• Brand Name: RESMED AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16132196
• MDR Text Key: 307081780
• Report Number: MW5114244
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1417685
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Patient Sequence Number: 1
• Treatment: BENICAR; CRESTOR; SYNTHROID
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White