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

Model Number L-4R

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2014

Event Type  No Answer Provided  

Event Description

Dealer alleged the battery contacts have melted to the floor shroud.

• 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: 3887192
• MDR Text Key: 20656416
• Report Number: 1531186-2014-02201
• 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: 06/20/2014,05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-4R
• 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: 06/20/2014
• Distributor Facility Aware Date: 05/22/2014
• Device Age: 7 YR
• Date Report to Manufacturer: 06/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other