MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-16 for TM-2100 manufactured by Critikon De Mexico.
[5644644]
The customer reported the treadmill accelerates on it's own several times over the last few months. Estop was not pushed during the reported incidents and no patient injury occured. The treadmill accelerated on its own and came back down to speed when manually adjusted. The customer also reported that the treadmill has run in reverse.
Patient Sequence No: 1, Text Type: D, B5
[13191170]
Patient information currently unavailable.
Patient Sequence No: 1, Text Type: N, H10
[39037339]
This complaint originated when a customer contacted ge healthcare after receiving the notification of 1651104-03/16/15- 002-c ((b)(4)) for uncontrolled motion. The customer stated they saw similar symptoms on their treadmill in the past but had not reported them. The customer reported the treadmill accelerated on it's own several times over the last few months and the treadmill came back down to speed when manually adjusted. The e-stop was not pushed during these incidents. The customer also reported that the treadmill had run in reverse in the past. The incidents occurred at unknown dates. The treadmill is currently in service and there is no evidence that the customer took any actions when the incidents occurred. 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 case system and treadmill were obtained. The treadmill and case logs were evaluated to confirm the behavior of the treadmill. In absence of particular dates, the treadmill log was examined for errors logged. Errors logged in the treadmill log were attempted to match to a stress test in the case log. The treadmill log shows that 2 drive communication errors were logged consecutively on (b)(6)-2014 while the belt was running. The belt was disabled as designed and communication was restored within 2 seconds. This occurrence is outside the case log date range so it could not be confirmed whether this occurred during a stress test. The expected behavior is that the belt would coast to a stop, so this does not match the reported incident. Nine other errors were logged while the belt was not running. Six of these occurred in the date range of the case log and it was confirmed that no stress test was being performed in each instance. Thus, these errors do not match the reported incident. No information could be found in the log files to support the treadmill accelerating on its own. The control board firmware does not issue speed commands to the drive except at commands from the case system. If the drive accelerated without commands from the firmware it would be expected that the drive would be experiencing some kind of error and drive errors would appear in the log while the belt was running. No error of this type appears in the log. A possible cause of the acceleration is user error--the user may have inadvertently pressed the exercise button on the host device, which would advance the stage of the exercise test, causing the treadmill to speed up. Expected to see in the case log in the instance of user error: 1) treadmill is started. 2) more than 1 exercise button press between pretest button and recovery or test end button. Inspection of the case logs show 3 stress tests that meet the above criteria. These 3 tests could be instances of user error that would cause the treadmill to speed up when it was expected to slow down. The case logs also indicate instances of the user pressing buttons inconsistent with the normal operation of a treadmill stress test. During 3 tests the user presses the recovery button while in the pretest phase which would have no effect. During 6 tests the start treadmill button is pressed while the treadmill was already running. During 7 tests the speed + button is pressed while the treadmill is not running. These instances indicate a pattern of user error in using the case buttons to run a stress test and to control the treadmill. There is no other information in the logs that indicate defective behavior of the case or treadmill, and no additional information can be obtained about the incident; therefore the probable root cause is user error. Correction: this report is not associated with a recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00008 |
| MDR Report Key | 4697343 |
| Report Source | 05,06 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-05-15 |
| Device Manufacturer Date | 2013-09-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 |