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

Device Problems Self-Activation or Keying (1557); Protective Measures Problem (3015)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

Customer stated that the treadmill moved up to its highest elevation and began to run in reverse.The customer also stated that the e-stop button was pressed, but the belt continued to run.No patient compromise reported.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Patient information currently unavailable.

Manufacturer Narrative

This complaint originated when a customer contacted ge healthcare after receiving the notification of fmi 30074 for uncontrolled motion (1651104-03/16/15- 002-c).The customer stated they saw similar symptoms on their own treadmill.A ge field engineer (fe) inspected the treadmill on site.The reported behavior could not be reproduced by the fe.Log files from the customer's treadmill and case system data from an exercise test were obtained.The customer indicated to the fe that the stress test data was from the test in which the incident occurred.The analysis of the log files and stress test data shows the following: at time 9:19:25 stress test started.At time 9:26:04 the treadmill belt was started 3 seconds before the start of bruce exercise protocol stage 1.At time 9:31:11 the treadmill belt was stopped 13 seconds into the recovery phase.The stress test data reports all treadmill speed and grade values according to the bruce protocol.No abnormalities can be seen in the log file or stress test data.Prior to this stress test there are 2 entries for emergency stop recorded at 8:48 and 8:50.These appear in the log as "emergency stop was initiated <00>", which is an e-stop command sent from the case, which are issued when the case stop treadmill button is pressed twice consecutively.When the e-stop button on the treadmill is pressed, the log will record the entry as "emergency stop was initiated <255>".This does not match the customer description of the reported incident.There are no errors or indication of any problems in the treadmill log associated with these e-stop entries.In the entire treadmill log there are 131 entries for e-stop commands issued from the case, thus the customer appears to regularly stop the treadmill in this way.The treadmill log file indicated no errors on (b)(6)-2015, the reported date of the incident, nor were any errors recorded in the previous 4 years.No additional information was obtained about this incident.Root cause is undetermined.Corrections: date of event is: (b)(6) 2015.The complaint is not related to fmi 30074.

• 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: 4711295
• MDR Text Key: 5665656
• Report Number: 3008729547-2015-00009
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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