MAUDE Adverse Event Report: WU'S TECH CO., LTD. DRIVE; POWERED WHEELCHAIR

Model Number	TITAN AXS
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a powerchair by an end user, who stated that "while driving forward, the speed increased drastically and the chair got rammed into her hospital bed, banging her leg into the metal frame," causing a "large lump" sticking out of her left leg.The end user went to the hospital, where it was determined that nothing was broken.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: POWERED WHEELCHAIR
• Manufacturer (Section D): WU'S TECH CO., LTD.; yuan peir st.; no. 225; hsin-chu city, hsinchu 30093 ; TW 30093
• MDR Report Key: 16294218
• Report Number: 2438477-2023-00006
• Device Sequence Number: 17742533
• Product Code: ITI
• UDI-Device Identifier: 00822383933924
• UDI-Public: 822383933924
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023
• Report Date (Section F): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TITAN AXS
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/05/2023
• Device Age: 4 YR
• Date Report to Manufacturer: 02/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 02/02/2023