MAUDE Adverse Event Report: RESMED CORP. AIR SENSE 10 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 1402353

Device Problems Device Emits Odor (1425); Pressure Problem (3012)

Patient Problem No Code Available (3191)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

I got a new resmed air sense 10 cpap to replace my older resmed cpap.I like to run my cpap with low humidity level.I normally set the humidity to 1 (out of 10).But i read that if i wake with a runny nose (which i do) it could mean that the humidity is too low.So i changed the setting to 4.I always fill the water tank every night, on the 1 setting it never runs out of water, however on 4 the machine used all of its water during the night.This loss of water causes the machine to start emitting terrible noxious fumes into my nose as i am sleeping.This made me very sick, also very difficult to wake, gases were giving me very painful nightmares, it was like i was being tortured and i couldn't escape.I explained to the medical supplier the issue i was having and he explained it was normal, and it was my fault for letting it run out of water.He said the fumes were not toxic without providing any evidence.There is nothing in the manuals about running the machine out of water creating toxic fumes.No warnings nothing.I cannot believe that the fda allows a "medical device" to emit toxic fumes for something as common as running out of water.Please help i don't know where else to turn.I need my machine to sleep, but the potential of getting gassed while sleeping makes me not want to use it.Fda safety report id# (b)(4).

• Brand Name: AIR SENSE 10 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 10137752
• MDR Text Key: 194929545
• Report Number: MW5094910
• 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: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1402353
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 136