MAUDE Adverse Event Report: GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LT OxyGo; Portable Oxygen Concentrator

Model Number	OxyHome
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) reports that he was sitting on his phone playing a game and decided to light a cigarette.He states he forgot he was wearing his nc with oxygen on.When he lit his lighter, the nc produced a fame.He immediately removed the oxygen the oxygen tubing and threw it to the floor then tuned off the oxygen flow.(b)(6) states the flame was extinguished and he had no pain so he did not call vitas to notify.(b)(6) states he replaced the oxygen tubing.Smoking cessation and xygen safety education was provided by nurse during visit.Per vitas nurse assessment patient sustained 2nd degree burn to right nare and tip of nostril as evidenced by scab.User facility/lmporter report number: (b)(4).
Additional Manufacturer Narrative
Handling plan: 1.Investigate the production batch records of this batch; 2.Trace the incoming batch of fire dampers used for this batch, check the incoming inspection records, and confirm the performance of the fire dampers; 3.Trace the performance inspection of this batch of products, confirm whether the oxygen concentration exceeds 93 ?? 3%; 4.Trace the version of the instruction manual of this batch, confirm that fire warnings have been carried out.Result: 1.The production batch records have been checked: lot 20240429.The products in this batch comply with the product inspection requirements.(attachment 1).2.The incoming inspection report of the fire dampers has been checked.The materials of this batch meet the requirements of material inspection.(attachment 2).Incoming batch number: 2024f031001, date of incoming: 2024-3-20.3.The inspection records of this batch of finished products have been checked.The oxygen concentration is 94.8%, and the oxygen production volume is 5l, which meets the standard requirements.(attachment 1) 4.The product manual of this batch contains a warning: do not allow smoking or open flames within the same room as the oxygen concentrator or any oxygen carrying accessories.(attachment 3) page 18, "warnings overview", item 5 manual version: m544-0125 v20 1170-540 attachment: m544-0125_oxyhome-instruction-manual_us_v20_flat 1400-5100 5.The labels of this batch of products bear the fire prevention symbol, and the surfaces of the equipment are also marked with the fire prevention symbol.(attachment 4, 5) conclusion: after investigation, this batch of products did not show any defects.This incident was caused by improper use of the user's product and was not a quality issue.Therefore, no corrective and preventive measures need to be initiated.

• Brand Name: OxyGo
• Common Device Name: Portable Oxygen Concentrator
• Manufacturer (Section D): GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LT; room a101, no.5 kesheng road,; no.1633 beitai road,; guangzhou, guangdong 51054 0; CH 510540
• Manufacturer (Section G): GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LT; room a101, no.5 kesheng road,; no.1633 beitai road,; guangzhou, guangdong 51054 0; CH 510540
• Manufacturer Contact: su zhanhui ; room a101, no.5 kesheng road,; no.1633 beitai road,; guangzhou, guangdong 51054-0 ; CH 510540
• MDR Report Key: 50863308
• Report Number: 3016809216-2026-00001
• Device Sequence Number: 18806822
• Product Code: CAW
• UDI-Device Identifier: 06921141405025
• UDI-Public: 06921141405025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/29/2024
• Device Model Number: OxyHome
• Device Lot Number: 20240429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Commode; M6 Tanks; OCD; Shower chair; Suction Machine
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 136 LB
• Patient Race: White