MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH; Active Wheelchair

Model Number	MOB1101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the wheelchair was received with the anti-tip wheels installed in the wrong position.While using the wheelchair inside his home on a tile floor, he was rolling backward when the wheelchair became caught on an object.The customer reported that when he attempted to continue moving backward, the wheelchair tipped over, causing him to fall.He reported striking his head and sustaining a fractured scapula.The customer sought medical attention in the emergency room.The customer stated that the anti-tip wheels were repositioned after the incident.
Additional Manufacturer Narrative
The product's anti-tip wheels are designed to swivel freely as part of their normal operation.

• Brand Name: VIVE HEALTH
• Common Device Name: Active Wheelchair
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 50234685
• Report Number: 50234685
• Device Sequence Number: 10273334
• Product Code: IOR
• UDI-Device Identifier: 00810113576879
• UDI-Public: 00810113576879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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
• Device Model Number: MOB1101
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2026
• Event Location: Home
• Date Report to Manufacturer: 08/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 140 LB