MAUDE Adverse Event Report: RESMED CORP. RESMED AIR SENSE 11 AUTOSET CPAP ELITE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 11

Device Problems Mechanical Problem (1384); Gas/Air Leak (2946); Material Deformation (2976)

Patient Problem Headache (1880)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Resmed model 11 cpap machine would not start.Display said "air leak, check side cover or humidity tank".I tried a new humidity tank with the same result.I woke up with a headache which, if continued, results in brain damage or death.I will go to urgent care today to get help, new cpap supplies because of 3 reasons.I cannot see my new (b)(6) doctor until march by schedule.My cpap supplier is 130 miles away (one way), so i cannot drive there for help.My health group "(b)(6)" has chosen (b)(6) as my cpap provider because they have lower prices.Troubleshooting, i noticed the silicone air seal attached permanently inside the humidity chamber cavity, looks deformed, after a year of use on this machine.Notice, this seal inside the machine is not replaced when a new humidity tank is supplied.

• Brand Name: RESMED AIR SENSE 11 AUTOSET CPAP ELITE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16312129
• MDR Text Key: 309206511
• Report Number: MW5114732
• 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: 02/02/2023

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 Model Number: 11
• Device Catalogue Number: 39420
• Device Lot Number: 1549458
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• Patient Sequence Number: 1
• Treatment: CLARITIN AS NEEDED; FLUTICASONE PROPIONATE NASAL SPRAY AS NEEDED; FUROSEMIDE 40MG PER DAY ; NALTREXONE 2.25 MG PER NIGHT FOR DEPRESSION; POTASSIUM CHLORIDE CRYSTAL ER30 MEN PER DAY ; VALSARTAN 160MG PER DAY
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native