MAUDE Adverse Event Report: RESMED CORP. RESMED AIRSENSE 10 AUTOSET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Pressure Problem (3012); Temperature Problem (3022)

Patient Problem No Code Available (3191)

Event Date 05/20/2020

Event Type  Injury  

Event Description

Resmed airsense 10 heated humidifier malfunction, 5 consecutive devices, plus one random device.The machine includes a heated humidifier that does not work.Without heat, and with higher pressure levels, e,g., 9" h2o and up the machine is intolerable due to severe drying of nasal passages and mouth, consequently the therapy is abandoned.Consequently life threatening problems are left untreated.I am a longtime user, 20 years, of cpap/apap due to aih levels over 130 and o2 sat.Levels under 90.Without treatment this is a life threatening issue.I have used every resmed apap machine with heated humidifiers since the autoset t.Their latest machine that i use is the air sense 10.The first machine i was issued worked perfectly for over 1.5 years, then failed.I have been issued 5 airsense 10 machines by (b)(6) to replace the first.The heater on every one is not functional.Consequently i have been unable to obtain successful therapy due to severe nasal dryness.(b)(6) is non responsive as they appear to lack competent technical help.The resmed machine has a problem, the heater does not work as needed.5 machines of mine and one identical of a friend have heaters that are not functional.Activating the warming function is supposed to turn on the heat plate to a temp.Of 154 degrees f.Only 80 degrees f is obtained.In addition the heater fails to operate during night time therapy.Consequently, due to extreme nasal dryness therapy is discontinued.My 20 years of successful treatment knows this is unacceptable.At higher pressures like mine, 10 " or more, without sufficient humidity, treatment cannot be tolerated.My friend, who's pressure is 4 to 6" does not notice the lack of humidity.My conclusion is that patients with low pressures may not notice, patients with higher pressures are likely part of the 50% that throw their machine in the closet.I am a retired electronics engineer, msee, and know that the resmed machines, except for the first, must be defective.Patients with low pressure or who are new to pap may not notice, but at my pressure 10" find unheated humidity intolerable.Novice users may not know what optimum therapy feels like, the serious dryness may result in death of people with aih levels like mine.My first machine worked properly, none of the five replacements worked properly, it's laterally killing me.(b)(6) is useless.My analysis of the problem is that it is a software bug.This bug can kill.Somehow resmed must be notified, (b)(6) is incompetent and cannot solve this problem.Please help, please investigate.Fda safety report id# (b)(4).

• Brand Name: RESMED AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 10108857
• MDR Text Key: 193776332
• Report Number: MW5094782
• Device Sequence Number: 5
• 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: 05/29/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 71 YR
• Patient Weight: 82