MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE DEVILBISS TRANSPORT/WHEELCHAIR CRUISERIII; WHEELCHAIR, MECHANICAL

Model Number	K320DDA-SF
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by an attorney alleging the right rear wheel fell off while in use.The end user fell and received bruises.The end user's wife pushing the wheelchair fell and broke her leg which required surgery.The device was returned for evaluation.Upon evaluation, the wheel on the left rear side had broken around the axle, preventing the wheel from staying on the axle attached to the wheelchair frame.Product labeling states, "large rear wheels should be inspected at least once a month to ensure proper tightness.If wheel wobbles or is loose, release lock nut and tighten axle bolt slightly.Test for proper tightness by leaning chair to one side and spin adjusted wheel." drive devilbiss healthcare is attempting to obtain additional information and will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS TRANSPORT/WHEELCHAIR CRUISERIII
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; no. 36 danyan road; danyan city, jiangsu 21230 0; CH 212300
• MDR Report Key: 21586185
• Report Number: 2438477-2025-00016
• Device Sequence Number: 15661699
• Product Code: IOR
• UDI-Device Identifier: 00822383123370
• UDI-Public: (01)00822383123370
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025
• Report Date (Section F): 03/12/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: K320DDA-SF
• Device Catalogue Number: K320DDA-SF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2025
• Event Location: Other
• Date Report to Manufacturer: 03/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 03/12/2025