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

Model Number	PHOENIXHD4-20
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a motorized scooter's battery charger by an end user, who stated that he "he plugged the charger into the wall connected to the scooter, and an electrical fire started." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The end user also confirmed that there was no property damage associated with the incident.He did not provide any information regarding the outlet involved in the incident.Drive will not be able to perform a product evaluation, as the end user confirmed that he disposed of the charger following the incident.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): WU'S TECH CO., LTD.; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• Manufacturer (Section G): WU'S TECH CO., LTD.; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• Manufacturer Contact: tim kao ; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• MDR Report Key: 17386416
• Report Number: 9616873-2023-00004
• Device Sequence Number: 17671730
• Product Code: ITI
• UDI-Device Identifier: 00822383579559
• UDI-Public: 00822383579559
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PHOENIXHD4-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Male