MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for LC9500RHR manufactured by Lifecore Fitness.
[90804197]
Patient Sequence No: 1, Text Type: N, H10
[90804198]
Patient was on the treadmill and selected the pause button to turn off the fan. The patient stepped on the treadmill while the belt speed was set at 3. 5. The patient fell when stepping back on to a moving treadmill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6993653 |
| MDR Report Key | 6993653 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-07-05 |
| Report Date | 2017-09-08 |
| Date Reported to FDA | 2017-09-08 |
| Date Reported to Mfgr | 2017-09-08 |
| Date Added to Maude | 2017-11-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | POWERED, TREADMILL |
| Product Code | IOL |
| Date Received | 2017-11-01 |
| Model Number | LC9500RHR |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFECORE FITNESS |
| Manufacturer Address | 5803 NEWTON DRIVE CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |