MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-16 for TM-2100 manufactured by Critikon De Mexico.
[5644636]
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.
Patient Sequence No: 1, Text Type: D, B5
[13198589]
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
Patient Sequence No: 1, Text Type: N, H10
[39256833]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00007 |
| MDR Report Key | 4697363 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-03-17 |
| Date of Event | 2014-08-20 |
| Date Mfgr Received | 2015-05-19 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2015-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | CRITIKON DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. |
| Manufacturer City | JUAREZ, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1651104-03/16/15- 002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM-2100 |
| Generic Name | POWERED TREADMILL |
| Product Code | IOL |
| Date Received | 2015-04-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO |
| Manufacturer Address | S. DE R.L. DE C.V. JUAREZ, MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-16 |