MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for BIODEX 945-385 manufactured by Biodex.
[40861131]
Patient walking on treadmill when sparks began to ignite from underneath treadmill. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060958 |
| MDR Report Key | 5513415 |
| Date Received | 2016-03-16 |
| Date of Report | 2015-03-15 |
| Date of Event | 2016-02-25 |
| Date Added to Maude | 2016-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | BIODEX |
| Generic Name | TREADMILL |
| Product Code | IOL |
| Date Received | 2016-03-16 |
| Model Number | 945-385 |
| ID Number | ID#32082 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIODEX |
| Manufacturer Address | SHIRLEY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |