MAUDE Adverse Event Report: NINGBO RUNMAI MEDICAL TECHNOLOGY CO., LTD. SUNSET 25FT OXYGEN SUPPLY TUBE - GREEN

Model Number	RES3025G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	01/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/16/2026, sunset healthcare solutions received an fda medwatch report that a vitas healthcare patient allegedly tripped on our res3025g oxygen supply tubing while walking to open her door.It was stated that she lost her balance and fell forward, resulting in a hip fracture requiring surgery.
Additional Manufacturer Narrative
N/a.

• Brand Name: SUNSET 25FT OXYGEN SUPPLY TUBE - GREEN
• Common Device Name: OXYGEN SUPPLY TUBE
• Manufacturer (Section D): NINGBO RUNMAI MEDICAL TECHNOLOGY CO., LTD.; no.777 binghai 4th road; hangzhou bay new zone; ningbo, zhejiang ; CH
• Manufacturer Contact: kitty sun ; no.777 binghai 4th road; hangzhou bay new zone; ningbo, zhejiang ; CH
• MDR Report Key: 24613087
• Report Number: 3006446479-2026-00001
• Device Sequence Number: 18551840
• Product Code: BYX
• UDI-Device Identifier: 00848530061081
• UDI-Public: (01)00848530061081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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 Model Number: RES3025G
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5L OXYGEN CONCENTRATOR; NEBULIZER; PORTABLE OXYGEN CONCENTRATOR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White