MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-26 for ISO1000 EXERCISE BICYCLE ISO1000 R * manufactured by Scifit Systems, Inc..
[4766651]
Gear would not engage. Pedals moved with no resistance. Evaluated by biomed: drive belt came off, replaced belt and adjusted bike tension. Function test completed and passed. Bike back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4143278 |
| MDR Report Key | 4143278 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-04-16 |
| Report Date | 2014-09-26 |
| Date Reported to FDA | 2014-09-26 |
| Date Reported to Mfgr | 2014-10-06 |
| Date Added to Maude | 2014-10-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISO1000 EXERCISE BICYCLE |
| Generic Name | EXERCISER, NON-MEASURING |
| Product Code | ION |
| Date Received | 2014-09-26 |
| Model Number | ISO1000 R |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCIFIT SYSTEMS, INC. |
| Manufacturer Address | 5151 SOUTH 110TH EAST AVE. TULSA OK 74146 US 74146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-26 |