MAUDE Adverse Event Report: FULL VISION COMPANY TM-2100-ST TREADMILL; TREADMILL, POWERED

Device Problem Protective Measures Problem (3015)

Patient Problems Fall (1848); Loss of consciousness (2418)

Event Date 07/01/2020

Event Type  Injury  

Event Description

This letter is to inform you of an event that occurred at the mayo clinic health system in mankato, minnesota on (b)(4) 2020 in which it was alleged that while using the tm-2100-st treadmill gedc-1603 the customer engaged the estop and it did not stop as expected and the patient fell and loss consciousness.No patient medical status or severity was made available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TM-2100-ST TREADMILL
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): FULL VISION COMPANY
• MDR Report Key: 17535189
• MDR Text Key: 321150284
• Report Number: MW5142088
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1