MAUDE Adverse Event Report: RESMED CORP AIRSENSE11 AUTOSET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Fluid/Blood Leak (1250); Noise, Audible (3273)

Patient Problems Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 06/29/2022

Event Type  Injury  

Event Description

I just started using the resmed airsense 11 c-pap machine on (b)(6).The manufacturer failed to program in my doctor's requested settings prior to shipping it to me so initially the pressure was too high, and the humidifier was not set properly so it irritated my airways causing sinus headache and a cough with phlegm.I had to have two telemedicine appointments to get the settings adjusted.Last night i discovered that the humidifier chamber is not sealing when closed, causing water to leak into the tubing which caused the machine to make a weird noise that luckily woke me up.However, the result of the water leaking from the defective seal on the humidifier chamber was pulmonary congestion and i have a cough with phlegm again today.(b)(4) sold the machine for resmed and neither are available today to report the complaint and said the humidifier container is on back order.I looked online and others have reported the same complaint with the humidifier chamber so i believe there is a design defect that could harm patients using the device if water ends up in the tubing and subsequently is delivered into their lungs.Fda safety report id # (b)(4).

• Brand Name: AIRSENSE11 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 14946694
• MDR Text Key: 295512758
• Report Number: MW5110725
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: XANAX 3 MG FOR CHRONIC INSOMNIA ONCE A DAY AT NIGHT; BREO INHALER; CARDIZEM CD 180 MG 2 X A DAY; CURCUMIN COQ10; LOSARTAN 100 MG; MAGNESIUM; MULTIVITAMIN; NEXIUM; PROBIOTIC; RED YEAST RICE; TYLENOL ARTHRITIS; ZYRTEC 10 MG 1 X A DAY
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White