MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-06-09 for TRAUMEX 80000GB NA manufactured by Fischer Imaging Corp..
[56197]
Traumex elevation drive continued downward after release of drive switch. Tech unlocked unit and moved arm away. No pt contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-1997-00004 |
| MDR Report Key | 97561 |
| Report Source | 06 |
| Date Received | 1997-06-09 |
| Date of Report | 1997-06-03 |
| Date of Event | 1996-12-08 |
| Date Facility Aware | 1996-12-08 |
| Report Date | 1996-12-09 |
| Date Mfgr Received | 1996-12-09 |
| Device Manufacturer Date | 1989-07-01 |
| Date Added to Maude | 1997-06-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAUMEX |
| Generic Name | RADIOGRAPHIC SYSTEM |
| Product Code | ITY |
| Date Received | 1997-06-09 |
| Model Number | 80000GB |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 96267 |
| Manufacturer | FISCHER IMAGING CORP. |
| Manufacturer Address | 12300 NORTH GRANT ST. DENVER CO 802413120 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-09 |