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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation has been completed and it has been confirmed that this event occurred due to recall fmi (b)(4) was not performed on this treadmill, which was to replace the drive motor to correct the uncontrolled motion.Fmi (b)(4) was not applied because of the inability to locate the device.Ge healthcare made three mandatory attempts at the time fmi (b)(4) was executed to locate this device but was unsuccessful.To correct this issue, a new drive motor was installed, and the device was returned to the customer for clinical use.No further actions are needed.

Event Description

This report summarizes 1 malfunction event.The customer alleges that the tm 2100 powered treadmill model number 2024315-001 sped up and then went in reverse.There was no patient on the treadmill at the time of the issue and therefore no injury occurred.

• 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: youssef halas ; 8200 west tower avenue; milwaukee, WI
• MDR Report Key: 8555978
• MDR Text Key: 146651974
• Report Number: 3008729547-2019-00003
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/26/2019

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?: No
• Device Operator: No Information
• Device Model Number: 2024315-001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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