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

Model Number J29194494F845

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problems Headache (1880); Nausea (1970); Dizziness (2194)

Event Date 01/18/2021

Event Type  Injury  

Event Description

I started using the philips dream machine (cpap machine) at the end of (b)(6) 2019.I did not notice any side effects.I started getting new daily chronic headaches in (b)(6), with nausea and dizziness.I didn't think it could be related to my cpap machine.I thought it was maybe due to stress.I saw my doctor at the end of (b)(6) when my headaches weren't responding well to advil/tylenol.She gave me triptan medication to try and also put me on fluoxetine.The headaches decreased somewhat, but still occurred daily (a dull headache upon wakening that persisted throughout the day).The nausea and dizziness still occur almost daily.My doctor then had me do an mri, which can back fine.Yesterday, on the news, i saw that my cpap machine has a recall due to deteriorating foam that can cause breathing issues and headaches.These foam particles are also carcinogenic, according to the report.I stopped using my machine last night and contacted my respiratory therapist and doctor.My respiratory therapist advised me to fill out an adverse reaction form.I am also going to register my machine with philips.I am still waiting to hear back from my doctor.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION (CPAP MACHINE)
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 12032056
• MDR Text Key: 257414772
• Report Number: MW5101965
• Device Sequence Number: 1
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J29194494F845
• Device Catalogue Number: DSX500T11C
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 101