MAUDE Adverse Event Report: RESMED CORP. AIRSENSE10 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRSENSE10

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Dry Mouth (4485)

Event Date 01/30/2022

Event Type  Injury  

Event Description

They use a resmed air sense 10 cpap machine for nightly use.Over the last several months i've been waking up with extremely dry sinuses and throat and airway which is leading to headaches.I thought perhaps i wasn't putting enough water in the reservoir because when i woke up it would always be empty.I started feeling it to the max line but i would still wake up with the reservoir completely empty and headaches.I even stopped using it nightly because the headaches and dry air was sometimes worse to deal with than my untreated sleep disorder.In january i traveled out of town and took my machine with me but i was using the machine on the carpeted floor and never noticed that the water was coming out of the reservoir.In february/march i traveled again but this time i placed my device on top of a bed side table.I noticed that in the mornings, the device would be sitting in a large puddle of water, long with electric lamps, chargers, cell phones, landline telephones and alarm clocks.I never suspected a failure of the water basin because i take it out, rinse it out and inspect it nearly every night.Now that i know that it's leaking, i've looked the basin over very carefully and i see no cracks, damage or any other signs of misuse or abuse on my part.It appears that it is strictly due to a manufacturing flaw that the water leaks out of the basin and all over the surrounding area where the device is located.Not only is that an electrical hazard a fire hazard a slip hazard, but it also leads to damage of personal property, like my bedside safe and its contents.For weeks the water drained unnoticeably out of the basin, made its way into the safe through the buttons on top and leaked down into the contents of the safe and rusted everything out inside the safe.For that same amount of time, i woke up with extremely dry sinuses, nasal passages, throat and lungs, due to a night of forced, dry air and it lead to drying up of mucous membranes, bloody nose, throat, neck and sinus pain in the mornings, and headaches.I tried contacting the device supplier to have the unit investigated, but i refused to investigate or service it due to an unpaid balance.I also contacted the resmed company directly to complain about the functionality of the system and they also refused to take or investigate my complaint saying that it was the responsibility of the supplier and the insurance company.Fda safety report id# (b)(4).

• Brand Name: AIRSENSE10 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 13692245
• MDR Text Key: 286871272
• Report Number: MW5107938
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AIRSENSE10
• Device Lot Number: 1440210
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: NAPROXEN ; TRAMADOL HCI AS NEEDED
• Patient Outcome(s): Disability; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Hispanic
• Patient Race: White