MAUDE Adverse Event Report: FULL VISION, INC. TRACKMASTER; TREADMILL, POWERED

Model Number TMX428 220V

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

Treadmill didn't advance automatically after the first level and had to be switched to manual mode.During the next transition to th3 3rd level the treadmill completely stopped.Pt was able to dismount safely.Manufacturer response for full vision treadmill, philips tmx 428 220 full vision treadmill (per site reporter).Ongoing difficulty with this device.

• Brand Name: TRACKMASTER
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): FULL VISION, INC.; 3017 full vision dr; newton KS 67114
• MDR Report Key: 16334022
• MDR Text Key: 309146266
• Report Number: 16334022
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TMX428 220V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1