MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-31 for NAUTILUS 800.6 manufactured by Nautilus Fitness.
[17889921]
In early march of this year the biomedical engineer dept was called about a malfunctioning nautilus treadmill located in the cardiac rehab dept the treadmill was removed from service, and taken to a repair area. The initial troubleshooting of the treadmill was halted when the technician working on it was electrically shocked while doing a walking test. The clinical equipment mgr was contacted, and found after repeated testing that the system was indeed conducting electricity from walking on the tread belt and holding onto the handrails. The faster the tread motor was ran the more voltage was conducted. The grounding of the system was checked from wall outlet through all ground wires and connectors and found to pass all required specs. We are concerned that this condition could repeat itself in similar units located within the cardiac rehabilitation dept and injure a pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012627 |
| MDR Report Key | 1469305 |
| Date Received | 2009-08-31 |
| Date of Report | 2009-08-19 |
| Date Added to Maude | 2009-09-16 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAUTILUS |
| Generic Name | TREADMILL |
| Product Code | IOL |
| Date Received | 2009-08-31 |
| Model Number | 800.6 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAUTILUS FITNESS |
| Manufacturer Address | 709 POWERHOUSE DR INDEPENDENCE VA 24348 US 24348 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-31 |