MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Unintended Ejection (1234); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 03/10/2020

Event Type  Injury  

Event Description

I am asking that you would remake the cpap machine to were it makes more sense.I have had off and on neck pain, on time i woke up in the middle of the night from turning so much the tubing was around my neck.Thought i was going to have a panic attack.The tubing is to long, to bulky heavy.My hair has been getting ratted up from wearing the harnesses across the top and the back of my head.I wore the piece that was under the nose and it didn't do anything, the one on my head was to top heavy and it kept falling off while i was sleeping.Every time i move/roll over i have to move the tubing with me so i am sitting up doing that.Because we are not give enough head gear these are not staying clean and the entire set up is so germy.I am getting off this machine next year because of the discomfort that it's made to me, by losing the weight and more weight i need to by (b)(6) of 2021.My physician said i can be retested if i lose the weight to get off the machine.To fix this problem the machines needed to be compacted.My machine takes up like almost 1/4 quarter of my night stand.The tubing is way too long and bulky, the nose pieces are not conformed to our noses and it's makes for a night of unrest when you have something attached to your entire head or around your entire head to your face and by twisting and turning your body to move your cpap machine tubing each time you move, this puts extra strain on your back and spine.I think you need lighter, shorter tubing and these need to be made into masks that we all get like 4 of them mailed to our home monthly, that will be automatically mailed out to us and then billed quarterly.The masks will be made by impression of your nose, this is how the nose piece needs to be made.We can take impressions of feet, teeth, hands ect., so why not conform these cpap machines to our noses.The nose piece will be attached inside a mask, and will be detachable to clean daily and then this will be constructed into a mask that only goes across a persons nose and checks, to then go over the persons ears to then be attached with small clip and or adjustable velcro strap.The nose pieces currently leak out too much air/and water from humidity.These would be cost efficient because it would cost as much less to mail them out, they wouldn't weigh as much and they would work more efficiently to determine if they are working properly or not to help any person who is on a cpap machine.The tubing would run under the nose piece or on the side of the nose piece instead of being attached to the end of the nose piece like mine is.The masks would be made with soft face clothes like the ones we are using for the washable face masks now during this covid pandemic but the area where the nose piece will be built in and with the nose piece being detachable, needs to have extra padding under the face cloth in tha area only so it's not rubbing onto your skin while sleeping.I just think is a much better option for making a machine that works to our own bodies and will be a lot more comfortable for anyone to wear.We won't have a head full or gear or anything over our face anymore that's super uncomfortable.We only need to be controlling where we breath, this is the only purpose that the cpap machine is for.People stop using the cpap machines due to the uncomfortness and also because they cannot pay for the supplies to maintain the machine to use it.Then you have the people who need the machines who flat out cannot afford to buy one for any start up fee no matter what it costs.I think this would be a great investment for the health and well being for everyone who uses a cpap machine.Thanks in a advance.(b)(6).The cpap machine that i am currently and have been using is the dream station by phillips and it uses the dream wear products to use the machine while sleeping.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12751762
• MDR Text Key: 280479305
• Report Number: MW5105137
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Patient Sequence Number: 1
• Treatment: CALCIUM SUPPLEMENT; EMERGEN-C VITAMIN PACK DAILY; FISH OIL PILL; LAMOTRAGINE; LISINOPRIL; MESALAMINE; METROPOROL; MULITIVITAMIN
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White