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

Model Number J253475608700

Device Problems Particulates (1451); Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Dizziness (2194); Anxiety (2328); Cognitive Changes (2551); Cough (4457)

Event Date 08/28/2019

Event Type  Injury  

Event Description

Initially got a cpap in (b)(6) of 2019.I experienced a lot of lightheadedness, disordered breathing, and anxiety in the daytime after using it.I had a repeat sleep study and was changed to bipap in (b)(6) 2019.I experienced symptoms such as headaches, lightheadedness, disordered breathing, cough (while using the device), nausea almost every morning, fatigue, brain fog and anxiety related to these symptoms.I told doctors that i felt like i was on a drug although hadn't taken any.I went through extensive testing.I was off work in 2020 for about 10 weeks and eventually accepted an early retirement (b)(6) of 2021.Symptoms have been such that i had to have groceries delivered at times and have limited the driving of long distances.I saw the black particles in the water chamber at times, but had no idea these were dangerous.Additionally, in (b)(6) of 2020 i purchased a so clean (ozone) device to sanitize the bipap.I was never told that this was dangerous or should not be used with the bipap.While some of my symptoms were pre-existing, they were not as significant.I believe my symptoms were aggravated by the device.There is currently not a replacement device and may not be one for a year or more, according to what i have been told.I underwent multiple tests throughout 2019, 2020, and 2021.I had mri of brain with and without contrast; eeg; hearing evaluation and vng; multiple consult with experts in neurotology, neuro-ophthalmology, headaches, etc.I had bloodwork and ot/pt.I need to rest a lot due to the fatigue and the brain fog.I am not going to list every single test here unless you call me and want the information.After everything i've been through i can't spend several more hours looking up dates and listing everything.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS BIPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12342829
• MDR Text Key: 267630442
• Report Number: MW5103343
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J253475608700
• Device Catalogue Number: DSX700H11C
• 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): Disability
• Patient Weight: 59