MAUDE Adverse Event Report: PHILLIPS/RESPIRONICS INC. DREAM STATION CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number REF# DSX200S11

Device Problems Degraded (1153); Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Sleep Dysfunction (2517)

Event Date 08/15/2020

Event Type  malfunction  

Event Description

From the start of using phillips cpap machine (b)(6) or (b)(6) 2019 there was an odor, didn't know there wasn't supposed to be.I started to notice being more awake for 2 weeks by middle of (b)(6) 2019 i stopped being awake.Kept telling dr n pharmacy that the machine must be broke cause it stopped working but they did not believe me.So i kept using machine hoping i would be awake again 1 day then lost hope but kept using machine cause they said i wasn't having apenic events which i discovered (b)(6) 2021 wasn't true that paper said the most i had we're 14 apenic events per hour but in different area it said 0 apenic events so my dr didn't look @ paperwork just the one spot.Sometime in 2020 or 2021 2 foam pieces fell out of tubes but i couldn't imagine how that happened so i didn't think about again until (b)(6) 2021 when i received the recall notice and read about foam pieces falling out of tubes n bad smell.Fyi: i did not use an ozone cleaner.I also stopped using machine against advice at the time i received recall notice cause i now knew it was affected n there was no way i was going use it again.Please make sure this phillips dream station cpap machine serial #(b)(4) ref# dsx200s11 is not used unless if it can be fixed.I keep worrying that at sometime i may get a serious med problem because i used this machine and inhaled those chemicals for close to 2 years and who knows if the foam went down my throat, which leads me to my next point, which is, i respectfully disagree with you about continue using the replaced machines until testing is complete.If they release voc's that's bad to me and i don't want a replacement either.I've been miserable for 19 years, only diagnosed 3 years ago, i've been waking up feeling like i haven't slept n sleep all day, can not clean my house talk on phone go out sometimes not cooking for my mom who lives with me n needs me to clean n cook and other things.But thankfully god makes it so ii get out of bed n makes it so i get up for dr appts and for other things now.But as horrible as it is i don't have cancer, hopefully won't get it from using the machine for as long as i did.So with the seriousness of med problems that can happen from voc's i surely don't believe any one should use it.It seems applied that the fda is allowing certain levels of voc's which i do not think right n don't agree with allowing certain levels of carcinogens in the water, so i use bottled for everything except bathing.But that's another subject.I am reporting this with hopes you, fda, won't allow this machine to go out to anyone else unless it can be properly fixed, really fixed.Thank you for your time.(b)(6).Fda safety report id #(b)(4).

• Brand Name: DREAM STATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS/RESPIRONICS INC.
• MDR Report Key: 15455765
• MDR Text Key: 300356126
• Report Number: MW5112138
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: REF# DSX200S11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White