MAUDE Adverse Event Report: C.T.M. TAIWAN MICROPORTABLE 4 WHEEL (BLUE) 9153645579; VEHICLE, MOTORIZED 3-WHEELED

Model Number PEGASUS4B-8

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It has been reported that the transaxle end of a pegasus4b-8 scooter is broken.

• Brand Name: MICROPORTABLE 4 WHEEL (BLUE) 9153645579
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): C.T.M. TAIWAN; no. 33-12, lin 1; chiu tou village; taoyuan hsien 327 ; TW 327
• MDR Report Key: 4339216
• MDR Text Key: 5217941
• Report Number: 1531186-2014-06404
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/15/2014,10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PEGASUS4B-8
• 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: 12/15/2014
• Distributor Facility Aware Date: 10/30/2014
• Device Age: 19 MO
• Date Report to Manufacturer: 12/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other