MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for SOLE F80 TREADMILL manufactured by Unk.
[130168276]
Treadmill increased speed on its own. I pressed control repeatedly to slow speed. It continued to increase speed causing me to fall. I had kill switch hooked to my shirt, which stopped treadmill after fall. Treadmill is a sole f80. Other serious / important medical incident: treadmill malfunctioned caused incident. Visited dr office next day. Is the product over-the-counter: yes. Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018. Reason for use: cardiac rehab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082021 |
| MDR Report Key | 8151302 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-12-05 |
| Date Added to Maude | 2018-12-11 |
| 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 | PATIENT |
| 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 | SOLE F80 TREADMILL |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2018-12-10 |
| Lot Number | 580816180603894 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-10 |