MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-08-05 for TRAUMEX 1100-01-002 NA manufactured by Fischer Imaging Corp..
[158965]
As a traumex system was being used during an exam, the down button got stuck, causing the system to continue to drive in the down direction. There was no patient injury or contact involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-1999-00004 |
| MDR Report Key | 235094 |
| Report Source | 05,06 |
| Date Received | 1999-08-05 |
| Date of Report | 1999-08-04 |
| Date of Event | 1999-07-15 |
| Date Mfgr Received | 1999-07-15 |
| Device Manufacturer Date | 1992-11-01 |
| Date Added to Maude | 1999-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | JANET PRIEUR |
| Manufacturer Street | 12300 NORTH GRANT STREET |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal | 80241 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAUMEX |
| Generic Name | RADIOGRAPHIC SYSTEM |
| Product Code | IYB |
| Date Received | 1999-08-05 |
| Model Number | 1100-01-002 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 227836 |
| Manufacturer | FISCHER IMAGING CORP. |
| Manufacturer Address | 12300 N. GRANT ST. DENVER CO 80241 US |
| Baseline Brand Name | TRAUMEX |
| Baseline Generic Name | RADIOGRAPHIC SYSTEM |
| Baseline Model No | 1100-01-002 |
| Baseline Catalog No | NA |
| Baseline ID | DX TRAUMEX |
| Baseline Device Family | TRAUMEX |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K880530 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-05 |