MAUDE Adverse Event Report: RESMED RESMED SYSTEM 9 WITH HUMIDIFIER; CPAP

Device Problems Defective Component (2292); Failure to Deliver (2338); Mechanics Altered (2984)

Patient Problems Fall (1848); Sleep Dysfunction (2517)

Event Date 11/11/2014

Event Type  Injury  

Event Description

I was rx'd a new resmed system 9.My old system 8 was still working fine.The system 9 daily ahi measurements started going up over 20 over often.I was told to ignore that.I finally realized that when i inhale with epr on, the system 9 does not keep up.I had the machine replaced under warranty.The new one did the same thing.I called the mfr, but they refused to discuss the issue with me.I wrote their ceo, but his rep claimed their machine works for "million" of cpap users.When you inhale with epr on, humidifier deployed, and pressure set to 6-7 as was the old machine, the machine delivers the air in stuttering spurts.It is incapable of delivering the air as a continuous ramp as you inhale.My daily ahi's went way out of treatment range (often 20-30).My sleep quality dropped.It affected my work.I have had two very bad falls at work since starting on the new machine, and it is possible that the poor treatment of the apnea was a contributor.The mfr takes a hands-off attitude toward pts, refusing them customer service.Their device is defective.They should and will be held accountable.The mfr instead insisted that i go to the people who sold the machine and who service it.(b)(6), in (b)(6).They could not find anything wrong with either machine i had tried.They often told me to ignore the ahi measurement that the machine provided.(nonsense, and dangerous) i complained to the physician who prescribed the new machine (dr.(b)(6)).He did a new overnight sleep study, (b)(6) 2016, which he had not done before, he prescribed the upgrade.They wired my legs with very uncomfortable electrodes and that resulted in a modest rls which i do not experience very often at home, and it has never been noticed by my sleep partner.Dr.(b)(6) prescribed meds for rls (off label parkinson's meds) which i did not take.He also suggested we try turning off the epr and run with fixed pressure at 6.I did that and the stuttering inhale problems went away.My sleep seems to have recovered.The ahi levels measured by their system 9 are now below 5 every day that i have checked, often below 3.It is absolutely clear that the resmed system 9 has a pressure sensor problem and/or a control problem such that it cannot deliver consistent airflow when you are inhaling at the pressure i was set for with epr on.The old system 8 does not do this.System 9 was not regulating pressure properly on inhalation.Poor sleep led to diminish life quality and job problems.I tried two system 9.Both failed in the same way.Warranty replacements were done for the flow generator and the humidifier with no improvement.

• Brand Name: RESMED SYSTEM 9 WITH HUMIDIFIER
• Type of Device: CPAP
• Manufacturer (Section D): RESMED
• MDR Report Key: 6371612
• MDR Text Key: 69021446
• Report Number: MW5068201
• Device Sequence Number: 2
• Product Code: BZD
• 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: 02/27/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SEVERAL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 78