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	Serious Injury
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, hsinchuq 30093 ; TW 30093
• Manufacturer (Section G): WU'S TECH CO., LTD.; yuan peir st. no. 225; hsin-chu city, hsinchu 30093 ; TW 30093
• Manufacturer Contact: tim kao ; yuan peir st. no. 225; hsin-chu city, hsinchu 30093 ; TW 30093
• MDR Report Key: 16821001
• Report Number: 9616873-2023-00003
• Device Sequence Number: 6820720
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female