MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for CASE T2100 TREADMILL manufactured by Ge Medical Systems Information Technologies.
[123709534]
The ge treadmill elevated and accelerated beyond their expected grade and speed targets. The device did not malfunction, rather, there were a series of key strokes and inputs from the user that made the device function in a way that was not expected (too fast and too steep). Ce believes there are negative "human factor designs" associated with the ge case treadmill t2100. Manufacturer response for treadmill, case t2100 (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7965108 |
| MDR Report Key | 7965108 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-11 |
| Report Date | 2018-09-27 |
| Date Reported to FDA | 2018-09-27 |
| Date Reported to Mfgr | 2018-10-15 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASE T2100 TREADMILL |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2018-10-15 |
| Model Number | T2100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 465 PAN AMERICAN DR STE 11 EL PASO TX 79907 US 79907 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-15 |