MAUDE Adverse Event Report: C.T.M. SHANGHAI SCOOTER MIDSIZE 4-WHEEL BLUE 9153650475; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-4B

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating that the control box is black, and the wiring harnesses are black and melted where they connected to controller.Dealer is stating that it looks like there was to many amp going into the charge.End user stated that they never saw fire, smoke or arching, and never smelled smoke.

• Brand Name: SCOOTER MIDSIZE 4-WHEEL BLUE 9153650475
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): C.T.M. SHANGHAI; 1158 yuan qu road; anting town; shanghai 2018 05; CH 201805
• MDR Report Key: 4453499
• MDR Text Key: 18545438
• Report Number: 1531186-2015-00579
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/26/2015,01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEO-4B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2015
• Distributor Facility Aware Date: 01/20/2015
• Date Report to Manufacturer: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other