MAUDE Adverse Event Report: INVACARE TAYLOR STREET SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403; VEHICLE, MOTORIZED 3-WHEELED

Model Number ZOOM 220

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

End user states that he broke the connector on the rear frame assembly that connects to the front frame and was looking for parts.

• Brand Name: SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4421829
• MDR Text Key: 5165220
• Report Number: 1525712-2015-00367
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2015

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: ZOOM 220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other