MAUDE Adverse Event Report: RESMED CORP RESMED AIRSENSE10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 37090

Patient Problem Aspiration/Inhalation (1725)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

I have a resmed airsense10 which is not one of the models listed on the recall list.The foam damping disintegrated.I felt it in my nose, turned off the machine and found there was a lot of foam floating on the surface of the water in the reservoir.I did notice the machine got louder for a couple of days prior to my discovering the foam so i was probably breathing it for a while.The machine was purchased new august 2021.

• Brand Name: RESMED AIRSENSE10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18826233
• MDR Text Key: 336943114
• Report Number: MW5152258
• 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: 02/28/2024

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 Catalogue Number: 37090
• Device Lot Number: 1531447
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White