FDA Adverse Event
Injury
Summary report: N
TREX
MDR report key: 288791
·
Received July 31, 2000
Report
- Report Number
- 288791
- Event Type
- Injury
- Date Received
- July 31, 2000
- Date of Event
- February 18, 2000
- Report Date
- February 28, 2000
- Manufacturer
- TREX MEDICAL CORP.
- Product Code
- JAA
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
X-RAY TUBE WAS BEING USED IN AUTO SET UP MODE. WHEN THE TUBE WAS ACTIVATED THE TUBE DROVE FORWARD AND ALMOST HIT THE PT. THIS IS THE SECOND TIME IN ONE YEAR. THE TABLE WAS IN A 90 DEGREE TILT WHEN THIS PROBLEM OCCURRED. THE PROBLEM WAS REPORTED TO THE DISTRIBUTOR. THEY DID A TEMPORARY REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREX | ROD AND FLORA UNIT | JAA | TREX MEDICAL CORP. | 6626-212A | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |