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

Device Problem Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi not applicable.Device evaluation anticipated, but not yet begun.

Event Description

Tm 2100 was found by a user going in backwards motion at 0.1 mph.The device was not in patient use, therefore no patient injury occurred.

Manufacturer Narrative

The investigation revealed the root cause of the treadmill belt running in a slow backwards motion was due to a random control pcb failure in the treadmill.The pcb has been replaced and the treadmill is working as intended and is back in-patient use.No adverse effects were identified as result of this issue.

• Brand Name: T2100 TREADMILL
• Type of Device: POWERED TREADMILL
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• MDR Report Key: 9878801
• MDR Text Key: 200644458
• Report Number: 3008729547-2020-00001
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1