MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	BLS18FBD-SF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a wheelchair by a provider, who reported that end user was sitting on the unit when it broke and "he fell through the chair." the end user is continuing a physical therapy program that began before the incident.There were no additional details on the severity of the injury provided with the initial complaint.Drive made multiple attempts to contact the reporter to investigate the incident, but did not receive a response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 16886747
• Report Number: 2438477-2022-00148
• Device Sequence Number: 6141947
• Product Code: IOR
• UDI-Device Identifier: 00822383241159
• UDI-Public: 822383241159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2023
• Report Date (Section F): 05/08/2023

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: BLS18FBD-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2022
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 05/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 05/08/2023