MAUDE Adverse Event Report: SYSMED (CHINA) CO., LTD. STRATUS 5 STANDING HOME OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number STR1005

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Dyspnea (1816); Fall (1848); Headache (1880); Muscle Weakness (1967); Arthralgia (2355); Cognitive Changes (2551); Increased Sensitivity (4538); Swelling/ Edema (4577)

Event Date 01/06/2023

Event Type  Injury  

Event Description

I have been on prescribed oxygen via a concentrator at home for nocturnal supplemental oxygen since late august/september of 2022.The company, (b)(4), sent a technician to my home on friday (b)(6) 2023 to evaluate and or service my oxygen concentrator supplied by (b)(4).The technician took the old unit away and replaced it with a different unit of the same model.I began to use the device that afternoon as i lay down for a nap, and approximately 30min after starting the machine with the nasal cannula in place delivering oxygen, i immediately had burning chest pain in both lungs roughly equal bilaterally that lasted acutely for around 5min, but began to subside to a more tolerable level within 15min after i immediately discontinued use of the device.About 20min after this acute pain, i attempted to use my incentive spirometer for breathing exercises as prescribed by my physicians.I was unable to do my breathing exercises with the spirometer due to sharp pains in my chest bilaterally with anything deeper than a half breath.I started to develop a new acute headache within 20-30min of exposure that lasted more than 72hrs and at it's worst, was unbearable with acute sensitivity to light, sound, or smells.Acutely within the 72-96hr period after exposure, i experienced full-body muscle and joint pains along with peripheral weakness in my lower extremities and hands.I have had numerous falls since the exposure due to new and worsening cognitive and neurologic symptoms.The peripheral weakness especially in my hands, arms, and legs is ongoing as of (b)(6) 2023 as are the worsened cognitive conditions.I have also had new joint swelling, redness, and pain acutely after exposure ongoing through the present.The hand weakness sometimes prevents me from opening a water or medicine bottle.The (b)(4) after hours emergency representative stated to the effect that she was "wondering if it (the unit) wasn't properly serviced" and that i should "definitely go get checked out (by a medical professional) for your health." i discovered that the intake filter, inside of the unit, second stage filter, and connected lines out to me all contained a white powder that fully impregnated the filters.The adapt health representative had no idea what the substance could possibly be and agreed that calling poison control was advisable.Poison control also strongly recommended getting immediate medical care, but stated that without understanding the context of where that device had been previously or comprehensive testing of the powder, there was little that could be done outside of symptom management and medical observation with follow-up care.I am continuing to receive follow-up care.I have the contaminated filters and consumables sealed in bags.No one from adapt health has followed-up to inquire about my health or testing of the device or in any other capacity related to the incident.I contacted (b)(4) around (b)(6) 2023 to ask where to submit my medical receipts related to ongoing medical testing and care related to the event.The representative did not have an answer, but said they would contact me to let me know.I have not heard from them as of 5:30pm et 2/13/2023.My providers are still unsure what i was exposed to, but the complexity and persistence of multiple new medical concerns that started or worsened after this exposure are causing my family and i a large amount of hardship from a health and general quality of life perspective.I am still looking for public and or private resources to help manage these burdens and to get further answers for my long-term health outlook.I have photos, records, recordings, the original contaminated materials, and additional dated narrative descriptions along with timelines and numerous corroborating healthcare providers and private individuals.Please let me know if there are any other supporting materials i can provide or if there are additional resources i may be able to utilize.The urine tox screen showed only the adderall which i am prescribed and take regularly.The chest x-ray performed at urgent care the next day was inconclusive due to technical errors and artifacts as a result of improper procedure in capturing the images.I have undergone and continue to undergo many additional labs and tests that are too extensive to include here and not yet all complete.The only medical device being used is the oxygen concentrator for nocturnal supplemental oxygen.A full active medication and supplements list can be shared upon request.

Event Description

Add'l info received on 03/03/2023 for report number: mw5114993.It is unclear yet if this is related to the sae, but we are working to get the substance tested to aid in the diagnostic/prognostic process and care planning.We have not yet been able to identify a lab or process for getting the potentially, hazardous substance i was exposed to during this sae tested.I am continuing to follow-up with my care team to diagnose the health impacts related to this exposure and prognostic implications along with a treatment and maintenance planning.The demyelinating process in the brain (central nervous system) regardless of causal etiology, is almost always irreversible.Our current goal is to determine if the damage is progressive/ongoing, to identify a treatment plan to slow or prevent further damage, and to understand what clinical/functional deficits may stem from this damage and what this will mean in terms of quality of life, normal functioning, and independence moving forward.We have several additional tests pending or that are scheduled.I and/or my healthcare providers intend to share any additional findings that may aid the fda in there oversight & enforcement activities related to this sae.Additionally, several attempts have been made to contact the supplier of the device and the device manufacturer, but there have been no replies to our inquires.The supplier was first notified the day of the exposure (06-jan-2023) and i called the manufacturer and left a voice message on 17-feb-2023.It is unknown to me whether or not this sae has been reported by the manufacturer or supplier.There has also been an oig-hhs healthcare fraud complaint submitted related to activities of the supplying company (b)(4).The oig-hhs complaint made 22-feb-2023 does mention the medwatch report that i have previously submitted and that i am continuing to work with my providers and the fda related to this reported sae.

Event Description

Additional information received on 3/17/2023 for mw5114993 for new mfr.

• Brand Name: STRATUS 5 STANDING HOME OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): SYSMED (CHINA) CO., LTD.; shenyang, hunnan 11017 1 CN
• MDR Report Key: 16386736
• MDR Text Key: 309763670
• Report Number: MW5114993
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Public: (01)0?955823000033OTS-5
• 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,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: STR1005
• Device Catalogue Number: CBVMQQ-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: N-ACEYTL CYSTEINE NAC 600MG PO BID; ONCE DAILY PO MULTIVITAMIN (MEN'S ONE-A-DAY); THE ONLY MEDICAL DEVICE BEING USED IS THE OXYGEN CONCENTRATOR FOR NOCTURNAL SUPPLEMENTAL OXYGEN. A FULL ACTIVE MEDICATION & SUPPLEMENTS LIST CAN BE SHARED UPON REQUEST.
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White