MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for T5XR manufactured by Nustep, Llc.
[124953319]
When inspecting unit at department opening, it was noted the seat was not working properly. The unit was pulled out of service for biomed inspection prior to any patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7999293 |
| MDR Report Key | 7999293 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-08-14 |
| Report Date | 2018-10-04 |
| Date Reported to FDA | 2018-10-04 |
| Date Reported to Mfgr | 2018-10-24 |
| Date Added to Maude | 2018-10-24 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2018-10-24 |
| Model Number | T5XR |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUSTEP, LLC |
| Manufacturer Address | 5111 VENTURE DR ANN ARBOR MI 48108 US 48108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |