MAUDE Adverse Event Report: C.T.M. SHANGHAI MICROPORTABLE 3 WHEEL (BLUE) 9153645576; VEHICLE, MOTORIZED 3-WHEELED

Model Number L-3B

Device Problems Alarm Not Visible (1022); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Provider states the battery gauge is not working, the dial will not move.Provider stated the end user had charged the unit and the scooter works fine, home use only.No further information provided.

• Brand Name: MICROPORTABLE 3 WHEEL (BLUE) 9153645576
• 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: 4435153
• MDR Text Key: 17580627
• Report Number: 1531186-2015-00451
• 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: 01/20/2015,01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-3B
• 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: 01/20/2015
• Distributor Facility Aware Date: 01/12/2015
• Device Age: 10 MO
• Date Report to Manufacturer: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other