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.
[5651315]
The customer reported that when they pushed the e-stop button during a study, the treadmill did stop within 2 seconds, but went in reverse for 2 seconds following the stop. No patient injury. Unknown which protocol was being used at the time of the event or what stage the protocol was at when the e-stop was pushed.
Patient Sequence No: 1, Text Type: D, B5
[13233839]
Patient information not known. 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
| Report Number | 3008729547-2015-00010 |
| MDR Report Key | 4712820 |
| Report Source | 05,06 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-16 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-04-16 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2015-05-20 |
| 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 | 2015-04-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |