FDA Adverse Event
Other
Summary report: N
DRX-REVOLUTION MOBILE X-RAY SYSTEM
MDR report key: 2805481
·
Received October 22, 2012
Report
- Report Number
- 1317307-2012-00008
- Event Type
- Other
- Date Received
- October 22, 2012
- Date of Event
- September 3, 2012
- Report Date
- October 22, 2012
- Manufacturer
- CARESTREAM HEALTH, INC.
- Product Code
- KPR
- PMA / PMN Number
- K120062
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT RECORD WAS LOADED ON THE MAIN SCREEN OF THE MOBILE X-RAY UNIT. JUST BEFORE THE RADIATION TECHNICIAN INITIATED THE PATIENT EXPOSURE, THE SCREEN GRAYED, REFRESHED, AND LOADED A DIFFERENT PATIENT. THE RADIATION TECHNICIAN NOTICED THE SCREEN CHANGE AND CLICKED OUT OF THE EXAM BEFORE INITIATING A PATIENT EXPOSURE. THE RADIATION TECHNICIAN THEN USED THE QUICK START MENU TO FIND THE CORRECT PATIENT AND FINISHED THE EXAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRX-REVOLUTION MOBILE X-RAY SYSTEM | MOBILE X-RAY SYSTEM | KPR | CARESTREAM HEALTH, INC. | DRXR-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |