MAUDE Adverse Event Report: C.T.M. SHANGHAI SCOOTER MIDSIZE 4-WHEEL SILVER 9153650474; VEHICLE, MOTORIZED 3-WHEELED

Model Number LEO-4S

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

End user advised drives for a couple of miles and when go over an incline scooter stops with no flashing lights.End user advised had to have someone help her home.End user advised can hear unit charging.End user advised charges unit in the garage and someone was working in the kitchen and had something plugged into that outlet and she has had issues since they used the plug with their adapter.Spoke with tech advised issue could be batteries.End user could not provide any further information.

• Brand Name: SCOOTER MIDSIZE 4-WHEEL SILVER 9153650474
• 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: 4495745
• MDR Text Key: 20122495
• Report Number: 1531186-2015-00858
• 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: Patient
• Type of Report: Initial
• Report Date: 02/06/2015,02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEO-4S
• 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: 02/06/2015
• Distributor Facility Aware Date: 02/02/2015
• Date Report to Manufacturer: 02/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other