MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for TERADMILL T635M manufactured by Sportsart.
[31002226]
Physical therapy staff member had a pt running at 5. 5 mph on the treadmill. The treadmill abruptly stopped with no warning. The pt lost balance due to sudden stop and jumped off but was not injured. After approx 30 seconds the treadmill started up again. Treadmill was taken out of service due to concerns of recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057784 |
| MDR Report Key | 5214083 |
| Date Received | 2015-11-05 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-10-28 |
| Date Added to Maude | 2015-11-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | TERADMILL T635M |
| Generic Name | TERADMILL T635M |
| Product Code | IOL |
| Date Received | 2015-11-05 |
| Model Number | T635M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPORTSART |
| Manufacturer Address | WOODINVILLE WA 98072 US 98072 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-05 |