MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS INC. DREAMSTATION; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DREAMSTATION HUM PACK DOM

Device Problem Break (1069)

Patient Problems Apnea (1720); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 08/01/2020

Event Type  Injury  

Event Description

So, the bipap stopped working correctly, the start date above is an estimate, and went on for several months.The pressure that was prescribed to me, by my physician stopped working correctly.Although the machine was still blowing air, it was not at the correct pressure required for me to achieve rem sleep.So although i was wearing and using the machine every night, it was not doing me any good.Because the machine was blowing air, and because there were no error messages, i was under the assumption that the machine was working correctly.Therefore because i was not getting any rem sleep, and because i stopped breathing several times, during the night, i could have had a heart attack, and i may have some undiagnosed heart condition.As time went along, i started to just go to sleep, for a couple of seconds uncontrollably without any notice all during the day.I would be drinking something, and the next thing i knew i had dropped it all over me, i dropped food all over me, there were times when i was driving, that while at a light, would go out for a couple of seconds, and as time went along it got worse and worse.I made an appointment with my sleep doctor but it would be some time before i could get in.My doctor prescribed a medicine providal, which is a stimulant, but not an amphetamine.After some time he increased the dose.This medicine did help for a few hours, but late in the afternoon i would start falling asleep again.Now under this condition, one is pretty foggy minded at all times, and not only can one not think straight, it is very difficult just to function.I did remember that i had a problem before with this type of bipap.When i was issued one of these and took it home, it would not work and came up with an error message.So the next day i took it back to we care, a va vendor.She was confused about the message so she called her contact for that manufacturer.I could hear the whole conversation, and the rep told her that the error message was for technicians only, and told her how to get rid of the message.She wanted to send that machine back home with me, but i refused, telling her that i had no confidence in that machine, she then got another machine from her inventory, set it up and i took it home.I cannot remember when, but that machine started have problems with maintaining the correct pressure, so my doctor ordered another machine.So after remembering the past episodes with that machine, that occurred a few years back, i decided to take an old machine of a different brand, got on the internet to learn how to set the pressure to my current pressure that was prescribed by my doctor, and set it, and used it that night.The next morning, i felt so much better, but was still not where i should be, but felt it would probably take a few days to actually start feeling better.I called the va and explained what was going on, and that i felt that this machine was not maintaining the correct pressure, and reviewed with her the history i have had with the dream station machines.She explained to me :"we have had problems with the machine, because it you get the valve wet, it wont blow right" i could not understand why the va was still using that brand.I also want to note that after i went to my sleep doctor and had a sleep study performed, it was discovered that my pressure needed to be increased.So that is why i did not feel as good as i should have with the old machine hooked up, although i felt a lot better, it still lacked the pressure i needed.Although i was getting some rem sleep, i wasn't obtaining rem during the whole night.I recommend that this machine be tested, and an investigation be conducted on this model.This machine is at the low end of 650 retail cost, about half the cost of similar machines.They may be cutting corners.I have had sleep apnea for many years, used many machines, and i have never had a problem until i used the dreamstation.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 10784862
• MDR Text Key: 221279101
• Report Number: MW5097622
• Device Sequence Number: 2
• Product Code: MNS
• 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: 10/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DREAMSTATION HUM PACK DOM
• Device Catalogue Number: REF DSX HCP
• Device Lot Number: DREAMSTNAUTO BI PAP
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 134