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.
[5665656]
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.
Patient Sequence No: 1, Text Type: D, B5
[13234569]
Ge healthcare's investigation is ongoing. A follow-up report will be submitted when the investigation is complete. Patient information currently unavailable.
Patient Sequence No: 1, Text Type: N, H10
[39234697]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00009 |
| MDR Report Key | 4711295 |
| Report Source | 05,06 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-23 |
| Date Mfgr Received | 2015-05-29 |
| Device Manufacturer Date | 2008-12-01 |
| 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 |