MAUDE Adverse Event Report: RESMED CORP. AIRMINI TRAVEL CPAP MACHINE BUNDLE WITH AIRFIT¿ P10 NASAL PILLOW MASK BUNDLE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problem Sneezing (2251)

Event Date 03/15/2023

Event Type  Injury  

Event Description

Sneezed horribly and starts in the middle of the night all three times, lasting 3 days.This happened on multiple trips while traveling from home.After the third time i gave up on the air mini.Each time i used it i was unable to work for several days.Changed hose and mask but did not help.I believe it is the humidex cartridge.If it is the whole concept of this machine is a failure.(i buy the stronger cartridge of the two but both caused reactions.).I tired changing cartridges suspecting they somehow changing the cartridge would help.I've used cpap machines for 12 years.I never had a problem except with the resmed air mini.Last 5 years have been on a resmed airsense 10.This is a defect product on the market in my opinion.

• Brand Name: AIRMINI TRAVEL CPAP MACHINE BUNDLE WITH AIRFIT¿ P10 NASAL PILLOW MASK BUNDLE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18994089
• MDR Text Key: 338932202
• Report Number: MW5153321
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALFUZOSIN HCL ER 24HR 10 MG ; FINASTERIDE 5 MG TAB ; MELOXICAN; PANTOPRAZOLE SODIUM EC 40 MG
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White