MAUDE Adverse Event Report: RESMED RESMED AIRSENSE 10 AUTOSET

Model Number AIRSENSE 10

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

I started using a new cpap machine, resmed airsense 10 autoset, on (b)(6) 2017.I was told that it could have leak issues with the humidifier chamber.The humidifier chamber is warranted for 90 days but replaced every 6 months.On approximately (b)(6) 2017, i awoke to water all over the floor, nightstand and inside the machine.This reoccurred 2 times before i realized that the chamber was defective.I hand wash unit, use distilled quality, soft water out of a commercial whole house system, don't overfill and have the heat on 4 out of 10.I filled the unit and let it sit on counter today, no leak.The more water in the tank, the more it leaks.The leaks occur after the machine is on, heated and i am asleep.My nightstand has electrical outlets built in.The water went into that area as well and ruined my furniture.Water and electricity don't mix.It is dangerous.You don't realize the thing is leaking until you wake up and find the mess.My other cpap unit's water tank leaked only when put into the dishwasher repeatedly.You knew it leaked as it would not hold water.This unit holds water until heated.The heat causes the metal bottom to expand and the seal to break over a period of time.It could ruin the unit.If the bulk of the water had entered the electrical part of my nightstand or a wall outlet, i don't know what would have happened.The unit should be recalled and redesigned as it is a potential electrical hazard.You fill the tank, no leak.You use the machine and you are asleep and it profusely leaks all of a sudden.Not good.

• Brand Name: RESMED AIRSENSE 10 AUTOSET
• Type of Device: RESMED AIRSENSE 10 AUTOSET
• Manufacturer (Section D): RESMED
• MDR Report Key: 7063402
• MDR Text Key: 93285572
• Report Number: MW5073579
• 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: 11/25/2017

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: AIRSENSE 10
• Device Catalogue Number: 37028
• Device Lot Number: 1225026
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 57