MAUDE Adverse Event Report: C.T.M. SHANGHAI MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT; 890.3800

Model Number L-4B

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2014

Event Type  No Answer Provided  

Event Description

Dealer stated that the motor's battery dies after driving two miles.Dealer stated the end-user was stranded near the fire department and had to seek technical assistance.Dealer stated no injuries.

• Brand Name: MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
• Type of Device: 890.3800
• Manufacturer (Section D): C.T.M. SHANGHAI; 1158 yuan qu road; anting town; shanghai 2018 05; CH 201805
• MDR Report Key: 4041199
• MDR Text Key: 18070568
• Report Number: 1531186-2014-03586
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/27/2014,08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-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: 08/27/2014
• Distributor Facility Aware Date: 08/01/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 08/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other