MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-09-01 for ASSY T2100 TREADMILL NEW DRIVE manufactured by Critikon De Mexico S. De R.l. De C.v..
[24763865]
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 information could not be obtained due to country privacy laws. Incident date unknown 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
[24763866]
The customer reported that the treadmill stopped working, and when running the calibration test on the t2100 the treadmill started to move in the opposite direction. No patient compromise reported.
Patient Sequence No: 1, Text Type: D, B5
[86899676]
Upon further review, ge healthcare has determined that the previously provided information in the initial report was incorrect. It has now been determined that the issue identified in this record is not related to the commutation loss. While a ge field service engineer was servicing the device, the treadmill failed the calibration test. As a result of this test failure, the treadmill was not returned to the customer, it was taken out of service. The issue was corrected by ordering and installing a new motor controller. All testing passed with the new motor controller installed prior to returning the treadmill to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2015-00013 |
| MDR Report Key | 5047442 |
| Report Source | FOREIGN |
| Date Received | 2015-09-01 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2015-09-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NURIKA BRAXTON |
| Manufacturer Street | 8200 W TOWER AVE |
| Manufacturer City | MILWAUKEE WI 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer G1 | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Street | CALLE VALLE EL CEDRO 1551 |
| Manufacturer City | JUAREZ 32575 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32575 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1825-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSY T2100 TREADMILL NEW DRIVE |
| Generic Name | POWERED TREADMILL |
| Product Code | IOL |
| Date Received | 2015-09-01 |
| Lot Number | SBC09044927SA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE EL CEDRO 1551 JUAREZ 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-01 |