MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMST AUTOSV H/C, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Catalog Number DSX900H11C

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Distress (2329); Cognitive Changes (2551); Chemical Exposure (2570)

Event Date 07/01/2023

Event Type  Injury  

Event Description

To whom it may concern: my name is (b)(6) , i reside in (b)(6).Fall 2020, i was diagnosed with severe obstructive sleep apnea.My sleep study identified a failure to breathe at 88 times per hour.During the overnight device assessment, the technician identified the need to transition from a c-pap machine to a bi-pap machine as my brain stopped responding to simple continuous airflow provided by the c-pap.To enable my breathing while asleep, i required a bi-pap machine which not only provides continuous airflow, it also ramps up with bursts of air when i cease to breathe which then forces me to take a breath.The lack of breathing in causes co2 (carbon dioxide) to build up in the brain which causes brain fog, headaches, and awakening from night terrors caused by my body's response to not breathing (similar to drowning).After fighting these battles all night, i am exhausted the next day - weak, unable to move without pain, and unable to concentrate (remember things, work complex issues, or generally "think") which has affected my ability to work or do daily tasks.Long term effects of untreated severe obstructive sleep apnea can lead to high blood pressure, diabetes, coronary artery disease, heart attack, heart failure, stroke, and death.Initial confusion from philips regarding their 'voluntary" recall of the c-pap and bi-pap devices, led my physician to approve ongoing use of my machine.Then came all the mail over the next year, 2022, identifying that people should stop using the devices all together.On (b)(6) 2022, i registered my device, and noted myself as the highest priority of "acute" via the philip's website for the recall, and received confirmation code: (b)(6) with instructions to monitor the following website for updates: www.Philips.Com/src-update.Due to my acute condition and the ongoing delay, i was forced to weigh the risk vs benefit of continuing to use my hazardous machine (i.E., suck in toxic chemicals or be able to function throughout the day).I would use the device for a few nights to clear my head and briefly stop the stress on my body; then, out of fear, cease using it for a few nights or until i was, once again, unable to function.In july, my device was putting out a horrible smell and its newly installed filter was discolored.I completely stopped using the device at that time and i am paying for it.Exhaustion, any movement stresses my body making it painful and difficult to do any task, including breathing.I struggle for words, thoughts, and memories.I am scheduled with a cardiologist for evaluation.To further my concerns, my sister applied for her replacement as soon as the announcements were made in early 2021 and didn't receive her replacement until summer of 2022 - she continued to use her contaminated device as she is a covid long hauler with breathing issues in addition to sleep apnea.It remains to be seen the long-term damage caused by use of her toxic device.I also have friends (a senior married couple and their adult son with autism), all were diagnosed with sleep apnea at the end of last year or earlier this year, and they have all received new philips devices!!! today is "(b)(6) 2023", and i have not received my device or any communication from anyone regarding my replacement.I have monitored the philips website, called their customer service number which only states that i have to refer to the website for any information as their representatives will not have any other information.I contacted the fda and was informed of numerous calls received regarding device replacement delays by philips.I was guided to complete the medwatch voluntary report (fda form 3500b) regarding my medical issues regarding this event.I was told that it is a matter of building a case before any action can be taken.Next recommended action was to contact the fda agency regarding regulatory misconduct by philips.I have made contact, and, per instructions, replied to email address: cdrhdeviceallegations@fda.Hhs.Gov.I request that any and all means be used to assure that philips is required to address my needs and the needs of any other people who have been waiting for relief from philip's faulty, toxic, and potentially long-term deadly devices.People may die or suffer in the future for their inexcusable delays.Note: i have additionally contacted (b)(6) these delays.The only other time that i have been this forceful for a resolution, the senators initiated a congressional investigation.Desperately requesting help and a response.Please save my life.(b)(6).Reference report: mw5144541.

• Brand Name: DREAMST AUTOSV H/C, DS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 17549358
• MDR Text Key: 321337232
• Report Number: MW5144540
• Device Sequence Number: 1
• Product Code: MNS
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE. ; OMEPRAZOLE.; VITAMIN D.
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White