FDA Adverse Event
Malfunction
Summary report: N
PACS SERVER
MDR report key: 2896719
·
Received December 28, 2012
Report
- Report Number
- 3004526608-2012-00005
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Report Date
- December 5, 2012
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- PMA / PMN Number
- K110875
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE RADIOLOGIST REPORTED THAT MEASUREMENTS FROM THE MODALITY (SIEMENS XA UNIT) ARE CORRECT BUT WHEN THE SAME AREA IS MEASURED IN PACS RA10000 WORKSTATION, THE MEASUREMENT IS NOT CORRECT. IT APPEARS AS THOUGH RA1000, BY DESIGN, MAY NOT BE TAKING ESTIMATED RADIOGRAPHIC MAGNIFICATION FACTOR INTO ACCOUNT WHEN CALCULATING MEASUREMENTS WHILE THE MODALITY DOES. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACS SERVER | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |