MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-21 for TM-2100 manufactured by Critikon De Mexico.
[5662072]
The customer reported that the treadmill seemed to run in reverse in the past and on another occasion go higher and faster when recovery was selected. No patient compromise reported.
Patient Sequence No: 1, Text Type: D, B5
[13156864]
Patient information currently unknown. Ge healthcare's investigation is ongoing. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[37768360]
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) to state that they had seen similar symptoms on their own treadmill in the past. The customer reported that the treadmill seemed to run in reverse, on another occasion went higher and faster when recovery was selected and when the estop on the treadmill was engaged it didn't slow down as fast as it should have. The incidents occurred at unknown dates in the past. The treadmill is currently in service. A ge field engineer (fe) inspected the treadmill on site and the reported behavior could not be reproduced. Log files from the customer's case system and treadmill were obtained by the (b)(4). 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 and estop behavior. Errors logged in the treadmill log were attempted to match to a stress test in the case log. The treadmill log shows that 3 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 3 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 in this instance, so this does not match any of the three reported issues. The communication errors, disabling of the belt, and restoration of communication would not have led to the treadmill running in reverse, the treadmill increasing both incline and speed, or the e-stop not functioning as intended. Nine other errors were logged while the belt was not running. Seven of these occurred in the date range of the case log and it was confirmed that no stress test was being performed in each case. Because the belt was not moving when the errors occurred, these errors do not match any of the three reported issues. Eleven times it was logged that the estop button was pressed with the belt running. The belt was disabled when the speed of the belt reached 0. In all cases the belt disable message was logged within 1 second of the estop message. There is no indication in the log of an e-stop taking too long. Investigation results: issue #1: the treadmill ran in reverse. No additional information could be obtained about this incident. The issue occurred at some unknown time in the past, and the treadmill was still used after it occurred, so obtaining the treadmill to further investigate root cause is unlikely to lead to any more specific conclusion. The probable root cause of issue # 1 is undetermined. Issue #2: treadmill increased speed and incline when recovery was selected on the case possible root cause: user error--if the user pressed the exercise button instead of the recovery button during a typical stress test it would be expected to see in the case log: treadmill is started, more than 1 exercise button press between pretest button and recovery or test end button. Inspection of the case logs show 4 stress tests that meet the above criteria on the dates (b)(6) 2014. These 4 tests could be instances of user error that would cause the treadmill to speed up when it was expected to slow down. 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. The issue occurred at some unknown time in the past, and the treadmill was still used after it occurred, so obtaining the treadmill to further investigate root cause is unlikely to lead to any other conclusion. Therefore the probable root cause is concluded to be user error. Issue #3: e-stop did not slow down the treadmill as quickly as it usually does as stated above, the treadmill logs show no indication of abnormal e-stop functionality. In every case the estop button was logged while the belt was moving, the belt speed reached 0 within 1 second which would be within normal performance, therefore no date on which an estop took too long could be identified. It is known that the estop does not stop the treadmill at the designed deceleration rate when the commutation loss drive error occurs. As noted in issue #1, the log files do not contain evidence of this situation occurring, and no additional information could be obtained about this incident. The issue occurred at some unknown time in the past, and the treadmill was still used after it occurred, so obtaining the treadmill to further investigate root cause is unlikely to lead to a specific conclusion. Therefore the cause of the issue is undetermined. Correction number was: 1651104-03/16/15- 002-c. Is: blank. This complaint is not related to the recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00011 |
| MDR Report Key | 4713526 |
| Report Source | 05,06 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-23 |
| Date Mfgr Received | 2015-05-19 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2015-05-19 |
| 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 | 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 | 2015-04-21 |
| 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 | 2015-04-21 |