MAUDE Adverse Event Report: SYSMED (CHINA) CO., LTD 3B MEDICAL STRATUS 5 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

As reported by christopher fink:" his oxygen concentrator was replaced as reported by christopher fink: "his oxygen concentrator was replaced.Within 30 min had burning in the lungs and developed a migraine.Was hurting to breathe in both lungs.He noticed that there was white powder in the machine.The next day he had body aches and joint pains.Had issues with joint pain and swelling with redness."d.Within 30 min had burning in the lungs and developed a migraine.Was hurting to breathe in both lungs.He noticed that there was white powder in the machine.The next day he had body aches and joint pains.Had issues with joint pain and swelling with redness.".

Manufacturer Narrative

The importer previously submitted a report stating that react health had received voluntary medwatch mw5115435.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: 3B MEDICAL STRATUS 5 OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): SYSMED (CHINA) CO., LTD; no. 299, baita third street; shenyang, liaoning cn 11016 9; CH 110169
• Manufacturer (Section G): SYSMED (CHINA) CO., LTD; no. 299, baita third street; shenyang liaoning, hunnan district, cn 11017 1; CH 110171
• Manufacturer Contact: marco marco mu ; 2219 rimlang drive, suite 301; bellingham, WA 98226 ; 3603257028
• MDR Report Key: 16779389
• MDR Text Key: 313677916
• Report Number: 3009096682-2023-00002
• 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: Health Professional
• 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 Model Number: STR1005
• Device Catalogue Number: CBVMQQ-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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 the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male