MAUDE Adverse Event Report: CRITIKON DE MEXICO TM-2100; POWERED TREADMILL

Device Problem Failure to Shut Off (2939)

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

Event Date 08/20/2014

Event Type  malfunction  

Event Description

The customer reported that they were unable to stop the treadmill during a patient procedure.The e-stop button and the treadmill stop button on the case console panel were pressed and the treadmill would not stop.The technician then turned the power off in back of the treadmill to stop it.There was no patient harm.

Manufacturer Narrative

Patient information currently unavailable.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Manufacturer Narrative

This complaint originated when a customer contacted ge healthcare after receiving the notification of fmi (b)(4) for uncontrolled motion (1651104-03/16/15- 002-c).The customer contacted ge to state that they had similar symptoms on their treadmill in the past.The customer reported being unable to stop the treadmill during a patient procedure.The treadmill would not stop by pressing the e-stop button or by pressing the treadmill stop button on the case console panel.The technician turned the power off in back of the treadmill to stop it.A ge field engineer (fe) inspected the t2100 treadmill on site.The reported behavior could not be reproduced.Log files were obtained by the fe and the log for sbc09085078sa does show entries on (b)(6) 2014 (the reported date of the incident).The entries are normal date and time set, and belt start and belt stop entries of a normal stress test.No e-stops are recorded on this date as would be expected per the complaint description.No under-voltage error entry was logged on this date as would be expected if the power was turned off with the belt running.No errors or warnings appear on this date in the treadmill log.No additional information could be obtained about this incident.The issue occurred 6 months before it was reported, and the treadmill remained in use.Root cause is undetermined.Could not duplicate the reported behavior and review of log files did not indicate cause of the reported behavior.(b)(4).

• Brand Name: TM-2100
• Type of Device: POWERED TREADMILL
• Manufacturer (Section D): CRITIKON DE MEXICO; s. de r.l. de c.v.; juarez, ; MX
• Manufacturer (Section G): CRITIKON DE MEXICO; s. de r.l. de c.v.; juarez, ; MX
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4697363
• MDR Text Key: 5644636
• Report Number: 3008729547-2015-00007
• 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: Foreign,Health Professional,User Facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1651104-03/16/15- 002-C
• Patient Sequence Number: 1