MAUDE Adverse Event Report: RESMED CORP RESMED AIRSENSE 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRSENSE11

Patient Problem Atrial Fibrillation (1729)

Event Date 08/08/2023

Event Type  Injury  

Event Description

I've been on cpap therapy for sleep apnea since early (b)(6) 2023 as a possible cause for atrial fibrillation.In those 2 months the system that records the data has been down twice, once for 2 weeks and now the latest for 9 days.The system is supposed to show me my sleep data in an app but the system is down again with no notification from the company when it will be fixed.This is a class ii medical device and i rely on it for my health.This is unacceptable.

• Brand Name: RESMED AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 17509686
• MDR Text Key: 321111745
• Report Number: MW5122985
• 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: 08/08/2023

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
• Device Model Number: AIRSENSE11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Patient Sequence Number: 1
• Treatment: ELIQUIS.; METOPROLOL.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native