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

Model Number DSX500T11W

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problems Dyspnea (1816); Headache (1880); Rash (2033); Dizziness (2194); Depression (2361); Respiratory Tract Infection (2420); Irritability (2421); Cognitive Changes (2551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/15/2018

Event Type  Injury  

Event Description

Dizziness, less cognitive, philips dreamstation caused me several severe medical issues.I am a (b)(6) woman, with minor health issues.I was using philips cpap dreamstation since (b)(6) 2018, (b)(6) 2018 i began having a runny nose every day, gums were sore and bleeding, could not take a deep breath, i was very restricted in breathing.My ears have been irritated and bothering me constantly.I get frequent sinus infections.I was concerned and mentioned it to my primary during my annual physical, my lack of being able to take a breath, like having severe pneumonia.Beginning in (b)(6) 2020 i started to have a horse voice every day, all day and it only got worse, a lump on my neck that would not go away and changed in size, i was very dizzy every day and when i got up i fell over or into furniture, bed spins, etc, headaches, skin rashes, acid reflux was every day, i was burping all the time and i never burped before, i mean never, less cognitive (was spacy could not remember simple tasks, usually i wake up and plan my day and tasks, i could do none of it, i was blank, forgot passwords, tasks, what i had previously accomplished).I was depressed over how stupid i had become.I stopped using dreamstation (b)(6) 2021 it is now (b)(6) 2021, my nose is not running every day, i am not dizzy, when i get up i do not fall over, or have trouble navigating walking to the bathroom.Headaches are better, my brain is clear, i can remember tasks, passwords.I feel so much better and i can function.For the last year and 1/2 i was so upset about my reduced capacities and abilities to accomplish simple life tasks or to function as a normal person.I am happy to be feeling so much better.I believe the cpap dreamstation caused the issues i was having, especially due to the fact that a month after stopping the use of the dreamstation there is a noticeable difference in all the areas i mentioned above.Dreamstation serial # (b)(4) and # (b)(4), i had 2 of them.(b)(6).I have 2 dreamstations i was using: dreamstation auto cpap hum dom (b)(4) dsx500h11 2017-12-18 rev00, dreamstnautocpaphumhtwifi dom (b)(4) 2017-01-05 rev00.Fda safety report id # (b)(4).

• Brand Name: PHILIPS CPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC
• MDR Report Key: 12518440
• MDR Text Key: 273574785
• Report Number: MW5104149
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022478
• UDI-Public: (01)00606959022478
• Combination Product (y/n): Y
• 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: 09/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DSX500T11W
• Device Catalogue Number: DSX500H11
• Device Lot Number: 2017-01-05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 100