MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. T2100 TREADMILL; TREADMILL, POWERED

Model Number 2024315-001

Device Problem Unintended System Motion (1430)

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

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information not available at this time.Reporter information: not available at this time.Ge healthcare was informed that the tm2100 sped up and slowed down during patient use. there was no patient impact or injury due to this event. it was concluded that fmi (z-1825-2015) was not applied to the device which would have prevented the treadmills uncontrolled motion. ge healthcare made 3 attempts to locate the device but was not successful.The fmi has since been applied to the tm2100 by updating the firmware and parameters in the t2100 treadmill motor controller.

Event Description

The customer alleges that the tm 2100 sped up.There was no patient injury.

• Brand Name: T2100 TREADMILL
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w. tower ave.; milwaukee, WI
• MDR Report Key: 9263159
• MDR Text Key: 209173711
• Report Number: 3008729547-2019-00010
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2024315-001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1