MAUDE Adverse Event Report: GUANGDONG PRESTIGE TECHNOLOGY CO., LTD. DRIVE; POWER SCOOTER

Model Number	FLEX-AUTO
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a power scooter by an end user, who stated that "his scooter was on his front porch and caught fire one afternoon.The fire department had to come and put the fire out." the end user also stated that "the scooter was not charging or plugged into an outlet." there was no report or evidence of illness, injury or medical treatment associated with the complaint.There was no information regarding whether the end user was storing his scooter outdoors on a regular basis.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: POWER SCOOTER
• Manufacturer (Section D): GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.; no. 8, road. 1, 3rd ind. distr; qiaotou area, houjie town; dongguan, guangdong 52395 0; CH 523950
• MDR Report Key: 16273308
• Report Number: 2438477-2023-00001
• Device Sequence Number: 12270409
• Product Code: INI
• UDI-Device Identifier: 00822383927350
• UDI-Public: 00822383927350
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/30/2023
• Report Date (Section F): 01/30/2023

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: FLEX-AUTO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2023
• Event Location: Home
• Date Report to Manufacturer: 02/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Date Report Sent to FDA: 01/30/2023