MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVEMEDICAL; WHEELCHAIR, MECHANICAL

Model Number	CX418ADDA-ELR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Concussion (2192); Convulsion/Seizure (4406)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by the provider who stated the end user was sitting in the wheelchair and a wheel broke causing the end user to fall to the floor.The end user was hospitalized with a concussion, seizures, and a forearm skin tear.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 heathcare evaluated the device that was returned for evaluation.The left front castor assembly was detached from the unit.Rust was present on brake locks and locking nuts were missing.The manufacturer has been informed of the evaluation and complaints data will continue to be monitored for trends.

• Brand Name: DRIVEMEDICAL
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297/799, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 23356429
• Report Number: 2438477-2025-00056
• Device Sequence Number: 9202742
• Product Code: IOR
• UDI-Device Identifier: 00822383528335
• UDI-Public: (01)00822383528335
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/24/2025
• Report Date (Section F): 11/24/2025

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: CX418ADDA-ELR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2025
• Device Age: 9 MO
• Event Location: Other
• Date Report to Manufacturer: 11/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 65 KG
• Date Report Sent to FDA: 11/24/2025