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

Device Problem Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2023

Event Type  malfunction  

Event Description

Good morning.I have an air sense 10, and last night i woke up to what appear to be pieces, tiny pieces, of plastic being shot into my mask and in my mouth.Do you know what could have happen? are there any recalls on this unit?.

• Brand Name: AIR SENSE 10 RESPOND
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16204625
• MDR Text Key: 307779794
• Report Number: MW5114371
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Patient Sequence Number: 1
• Patient Sex: Male