FDA Adverse Event
Malfunction
Summary report: N
DRX-REVOLUTION
MDR report key: 3030025
·
Received March 28, 2013
Report
- Report Number
- 3030025
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 9, 2013
- Report Date
- March 28, 2013
- Manufacturer
- CARESTREAM HEALTH, INC.
- Product Code
- IZL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
AROUND 0330 A RETROGRADE URETHROGRAM WAS PERFORMED BY DR. A IMAGE WAS OBTAINED PER PROTOCOL DURING INJECTION OF CONTRAST. THE DIGITAL PORTABLE UNIT #3 WAS USED. DR VIEWED THE IMAGE PRIOR TO REPROCESSING. AT THAT POINT THE IMAGE BECAME NON-DIAGNOSTIC. DR WAS SATISFIED WITH THE IMAGE AND CONTINUED PATIENT CARE. NEITHER OF THE DOCTORS WANTED A REPEAT EXAM. I LATER NOTIFIED THE DOCTORS THAT THE IMAGE WAS UNRECOVERABLE.RADIOLOGY SUPERVISOR SPOKE WITH CARESTREAM SERVICE ENGINEER WHO STATED THAT THEY IDENTIFIED THE SOFTWARE MALFUNCTION AND WILL BE APPLYING A SOFTWARE PATCH TO CORRECT THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128681 | DRX-REVOLUTION | SYSTEM, X-RAY, MOBILE | IZL | CARESTREAM HEALTH, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |