MAUDE Adverse Event Report: WU'S TECH CO., LTD. DRIVE MEDICAL; POWER, POV, 4 WHEEL

Model Number	SFSCOUT4
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified on (b)(6) 2022 regarding a sfscout4, a compact power scooter that is "getting a 5 beep code".The end user has changed the batteries since purchased in 2017.The end user also states that "the scooter tipped over the first time about 4 years ago, the scooter tipped over a second time about 2 years ago.The end user received broken hips on both occasions due to this scooter tipping over.1st incident: drove off of small ramp, fell on hip and had partial hip replacement 2nd incident: scooter tipped over while driving down small ramp" customer admits that they are at fault.Currently, this device will not be returned for evaluation.Drive devilbiss healthcare 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 MEDICAL
• Common Device Name: POWER, POV, 4 WHEEL
• Manufacturer (Section D): WU'S TECH CO., LTD.; no. 225, yuan peir st.; hsin-chu, hsinchu, tw 30093 ; TW 30093
• Manufacturer (Section G): WU'S TECH CO., LTD.; no. 225, yuan peir st.; hsin-chu city, hsinchu 30093 ; TW 30093
• Manufacturer Contact: tim kao ; no. 225, yuan peir st.; hsin-chu city, hsinchu 30093 ; TW 30093
• MDR Report Key: 16820907
• Report Number: 9616873-2023-00002
• Device Sequence Number: 6987479
• Product Code: INI
• UDI-Device Identifier: 00822383519098
• UDI-Public: 822383519098
• Combination Product (Y/N): N
• 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): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SFSCOUT4
• Was Device Available for Evaluation?: No
• 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): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG