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

Model Number TITAN AXS

Device Problem Unintended Collision (1429)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 308751888
• Report Number: 2438477-2023-00006
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TITAN AXS
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2023
• Distributor Facility Aware Date: 01/05/2023
• Device Age: 4 YR
• Date Report to Manufacturer: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female