MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2015-01-13 for TM-2100 manufactured by Critikon De Mexico.
[13031841]
Investigation revealed the runaway condition was able to be recreated when a high impedance ground connection (marginal ground connection) going from the drive to the encoder was simulated by adding a 24 ohm resistor in series with the ground line. The effect was a reduced encoder voltage causing the encoder not to function as intended. This resulted in a loss of commutation in the motor that caused the treadmill belt to run in an uncontrolled manner. The exact cause of the commutation loss is not known and the event has not been duplicated without the addition of resistance to the encoder ground line. A design mitigation has been proposed by (b)(4) that will detect commutation loss and disable the drive when the reported condition occurs. This mitigation will be implemented to correct the impacted treadmills in the field.
Patient Sequence No: 1, Text Type: N, H10
[16558320]
The customer reported that while doing a bruce protocol stress test, the treadmill went into overdrive when going into stage 4. When the kill-switch was hit, the treadmill slowly reduced speed to fully stop instead of being instantaneous. The emergency stop button also did not work as expected. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16694663]
Patient information is unknown. Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00001 |
| MDR Report Key | 4414476 |
| Report Source | 01 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-12-17 |
| Date Mfgr Received | 2015-02-25 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2015-02-03 |
| 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 | 2015-01-13 |
| 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 | 2015-01-13 |