MAUDE Adverse Event Report: SYSMED (CHINA) CO., LTD SRATUS 5; 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

According to mw5114993 - "i have been on prescribed oxygen via a concentrator at home for nocturnal supplemental oxygen since late (b)(6) 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.

Manufacturer Narrative

The importer previously submitted a report stating that react health had received voluntary medwatch mw5114993.Multiple attempts were made to have the device returned for evaluation.The device has not been returned.The importer believes they will not be able to obtain the device and are filing a final report.If further information becomes available a follow-up report will be filed.

• Brand Name: SRATUS 5
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): SYSMED (CHINA) CO., LTD; no. 299, baita third street; hunnan district, shenyang liaoning, cn 11017 1; CH 110171
• Manufacturer (Section G): SYSMED (CHINA) CO., LTD; no. 299, baita third street; hunnan district, shenyang liaoning, cn 11017 1; CH 110171
• Manufacturer Contact: marco mu ; 2219 rimlang drive, suite 301; bellingham, VA 98226 ; 3603257028
• MDR Report Key: 16779338
• MDR Text Key: 313692124
• Report Number: 3009096682-2023-00001
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STR1005
• Device Catalogue Number: CBVMQQ-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2024
• Date Report to Manufacturer: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other