FDA Adverse Event
Injury
Summary report: N
PICOM POWERCONSOLE
MDR report key: 2978463
·
Received February 19, 2013
Report
- Report Number
- MW5029073
- Event Type
- Injury
- Date Received
- February 19, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 19, 2013
- Manufacturer
- SCIMAGE INC.
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
RADIOLOGIST ATTEMPTED TO OPEN CASE (B)(6) BUT RECEIVED A MESSAGE THAT SOMEONE ELSE WAS ALREADY READING IT. SHE MOVED ON AND OPENED ANOTHER CASE (B)(6). THE CASES AND REPORT PANE LOADED AS NORMAL WITH BOTH PACS DISPLAYS LOADED WITH IMAGES FROM THE CURRENT CASE. IN THE TOP LEFT OF PACS VIEWER, THE CURRENT CASE WAS LISTED AS WELL AS WHAT LOOKED LIKE A PRIOR CT FOR THE SAME PT. HOWEVER ON CLOSER EXAMINATION, WHEN THE RADIOLOGIST DRAGGED THE SERIES DOWN FORM THE TOP LEFT OF THE PACS VIEWER WHERE PRIORS ARE LISTED, THE PRIOR ON THE LIST WAS ACTUALLY THE CASE FROM THE PREVIOUS PT, (B)(6). PICOM POWERCONSOLE 5.24.0.12 AND XYZ VIEWER 5.5.4.8 - ERROR REPORTED (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72780 | PICOM POWERCONSOLE | PICOM PACS | LLZ | SCIMAGE INC. | POWERCONSOLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |