MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION 2 AUTO CPAP ADVANCED; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Headache (1880); Sleep Dysfunction (2517)

Event Date 12/15/2023

Event Type  Injury  

Event Description

I have a dreamstation 2 that i received from philips after my first cpap machine was recalled.The first thing i noticed was the hose was not heated and would get quite cold during the night.So i bought a hose cover which helped a little bit since the cold hose wasn't against my body.I also checked the heater plate when i first started the machine at night, and it seemed to be working okay.(to be honest, i wasn't terribly happy with the new machine but assumed it was because i was used to my old one which i had for about six years.) then i found that i was waking up in the night because the cpap air was so cold and that had nothing to do with the hose not being heated.I now know that the heat plate was heating slightly when i first turned on the unit but stopped heating after only a couple of minutes.It wasn't overheating, it wasn't heating properly.I continued to use the cpap until late january when i realized that i was waking up most mornings with a headache after a restless night.I have no idea what was causing the headaches, but they stopped after i stopped using the machine.I haven't used it since then but was unsure what to do about it.I was going to try to buy a new machine, but my insurance won't cover it unless my doctor orders a new sleep study.And i have just been assigned to a new primary provider at the clinic because my previous provider has moved away.(i'm sure it will come as no surprise to anyone that medical professionals are leaving the field and patients are left in the lurch.) anyway, i finally have an appointment scheduled for next month and may be able to persuade the new provider to help me.In the meantime, i don't use the cpap and rely on sleeping in a recliner that allows my head to be elevated and seems to alleviate the snoring.Thank you for your time and attention, (b)(6).Reference report #mw5153823.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 19104506
• MDR Text Key: 340356277
• Report Number: MW5153822
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 83 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White