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	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user called to report a "5 beep code" on the unit's battery.This error code belongs to the abnormality of theelectromagnetic brake circuit.If it is in this state and the clutch handle is released, it will be in a non-braking state, resulting in thepossibility of rollover.

• 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 city, hsinchu tw 30093 ; TW 30093
• Manufacturer (Section G): WU'S TECH CO., LTD.; no. 225, yuan peir st.; hsin-chu, hsinchu tw 30093 ; TW 30093
• Manufacturer Contact: tim kao ; no. 225, yuan peir st.; hsin-chu, hsinchu tw 30093 ; TW 30093
• MDR Report Key: 16275500
• Report Number: 9616873-2023-00001
• Device Sequence Number: 4942817
• Product Code: KNN
• UDI-Device Identifier: 00822383519098
• UDI-Public: 00822383519098
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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
• Device Model Number: SFSCOUT4
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown