MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD DRIVE; WHEELCHAIR

Model Number	DFL19-BL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Concussion (2192)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transport chair by an end user, who stated that as she attempted to sit in the chair, she "was holding onto the arm rests [and].When she sat down the chair tipped over backwards and hit the back of her head on the pavement." the end user reported that she sustained a concussion and sought medical treatment, including medication for headaches and nausea.The end user confirmed that there was no defect detected with her unit.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD; no.36 danyan road; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 17399024
• Report Number: 2438477-2023-00105
• Device Sequence Number: 12245065
• Product Code: IOR
• UDI-Device Identifier: 00822383137377
• UDI-Public: 822383137377
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 07/26/2023

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: DFL19-BL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2023
• Event Location: Other
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 07/26/2023