MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-15 for PRO1000 PRO 1000 * manufactured by Scifit Systems, Inc..
[16752511]
Clinical engineer's pantleg was caught on the adjustable extension shafts, which pulled his leg toward the pinch point on the ergometer. No injury, though it potentially could cause a sprain. A good solution would to place a soft cover over the shafts or redesign the assembly somehow. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3072527 |
| MDR Report Key | 3072527 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-03-29 |
| Report Date | 2013-04-15 |
| Date Reported to FDA | 2013-04-15 |
| Date Reported to Mfgr | 2013-04-23 |
| Date Added to Maude | 2013-04-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO1000 |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2013-04-15 |
| Model Number | PRO 1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 7 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 | 2013-04-15 |