MAUDE Adverse Event Report: SOLE F80 TREADMILL; TREADMILL, POWERED

Lot Number 580816180603894

Device Problem Self-Activation or Keying (1557)

Patient Problem Fall (1848)

Event Date 12/05/2018

Event Type  Injury  

Event Description

Treadmill increased speed on its own.I pressed control repeatedly to slow speed.It continued to increase speed causing me to fall.I had kill switch hooked to my shirt, which stopped treadmill after fall.Treadmill is a sole f80.Other serious / important medical incident: treadmill malfunctioned caused incident.Visited dr office next day.Is the product over-the-counter: yes.Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.Reason for use: cardiac rehab.

• Brand Name: SOLE F80 TREADMILL
• Type of Device: TREADMILL, POWERED
• MDR Report Key: 8151302
• MDR Text Key: 130168276
• Report Number: MW5082021
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 580816180603894
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR