MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-05-05 for TRAUMEX DR-9000 * manufactured by Fischer Imaging Corp..
[16793029]
Technician was moving the image array over the top of the table, when the technician pressed both the rotate button ans sid release button he was unable to control the movement and it rotated freely, striking the exam table. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-2004-00003 |
| MDR Report Key | 559271 |
| Report Source | 08 |
| Date Received | 2004-05-05 |
| Date of Report | 2004-05-04 |
| Date of Event | 2004-04-13 |
| Date Mfgr Received | 2004-04-13 |
| Date Added to Maude | 2004-12-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GARY TURNER |
| Manufacturer Street | 12300 NORTH GRANT ST. |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal | 80241 |
| Manufacturer Phone | 3032542525 |
| Manufacturer G1 | FISCHER IMAGING CORP. |
| Manufacturer Street | 12300 NORTH GRANT ST. |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80241 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAUMEX |
| Generic Name | GENERAL RADIOGRAPHIC SYSTEM |
| Product Code | ITY |
| Date Received | 2004-05-05 |
| Model Number | DR-9000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548985 |
| Manufacturer | FISCHER IMAGING CORP. |
| Manufacturer Address | 12300 NORTH GRANT ST. DENVER CO 80241 US |
| Baseline Brand Name | TRAUMEX |
| Baseline Generic Name | GENERAL RADIOGRAPHIC SYSTEM |
| Baseline Model No | DR-9000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-05 |