MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL DRIVE DEVILBISS HEALTHCARE POLYFLY WHEELCHAIR; CHAIR, WITH CASTERS

Model Number	TR18
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by the end user's daughter who stated the wheel locks did not engage, and the wheelchair moved as the end user attempted to sit down.The end user subsequently fell, sustaining a femur fracture.Surgical intervention was required, and the individual is currently receiving continued care in a rehabilitation facility.The product labeling for this wheelchair instructs users to engage the dual wheel locks against the rear tires and to ensure the front casters are positioned forward before entering or exiting the chair.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported an incident involving a wheelchair by the end user's daughter who stated the wheel locks did not engage, and the wheelchair moved as the end user attempted to sit down.The end user subsequently fell, sustaining a femur fracture.Surgical intervention was required, and the individual is currently receiving continued care in a rehabilitation facility.The product labeling for this wheelchair instructs users to engage the dual wheel locks against the rear tires and to ensure the front casters are positioned forward before entering or exiting the chair.The device was returned for evaluation.During evaluation, the rear wheel brakes were confirmed to function as intended.The manual includes a warning instructing users to engage the dual wheel locks on both rear wheels before entering or leaving the chair.It is unclear whether the rear wheel locks were engaged prior to the end user getting into the chair, as instructed in the manual.An issue identified during evaluation involved the hand rim brake, which is primarily intended for use while the user is already seated.The brake pad was misaligned with the hand rim due to a loose c-shaped metal bracket that secures the brake assembly to the frame.The right bracket detached during inspection.The loosened screws in the bracket allowed the brake assembly to move, resulting in misalignment between the hand rim and brake pad.It is possible that the bracket was not tightened appropriately during attachment of the extension.

• Brand Name: DRIVE DEVILBISS HEALTHCARE POLYFLY WHEELCHAIR
• Common Device Name: CHAIR, WITH CASTERS
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL; no 297,chuqiao road,; zhenjiang city, jiangsu ; CH
• MDR Report Key: 24283104
• Report Number: 2438477-2026-00010
• Device Sequence Number: 18623718
• Product Code: INM
• UDI-Device Identifier: 00822383132044
• UDI-Public: (01)00822383132044
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TR18
• Device Catalogue Number: TR18
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2026
• Event Location: Home
• Date Report to Manufacturer: 04/29/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/29/2026