FDA Adverse Event
Malfunction
Summary report: N
VITREACORE
MDR report key: 3440504
·
Received September 12, 2013
Report
- Report Number
- 2134213-2013-00004
- Event Type
- Malfunction
- Date Received
- September 12, 2013
- Date of Event
- August 7, 2013
- Report Date
- August 7, 2013
- Manufacturer
- VITAL IMAGES, INC.
- Product Code
- LLZ
- PMA / PMN Number
- K071331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT AFFECTS VERSIONS 6.0, 6.1, 6.2, 6.3, 6.4 AND THEIR UPGRADES. IT ALSO AFFECTS THE INITIAL BASE VERSION OF 6.5.
Description of Event or Problem · 1
THE VITREACORE ISSUE WAS REPORTED INTERNALLY. DURING INTERNAL TESTING WE FOUND THAT THE VITREACORE 3D MAY GENERATE INCORRECT IMAGE ORIENTATION AND IMAGE POSITION IN THE DICOM FILE CREATED WHEN TAKING A SNAPSHOT OF AN MPR VIEW. THIS ERROR MAY RESULT IN WRONG ORIENTATION MARKERS BEING DISPLAYED WHEN THE DICOM FILE OF THE SNAPSHOT IS VISUALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459339 | VITREACORE | PICTURE ARCHIVING AND COMMUNICATIONS SYS | LLZ | VITAL IMAGES, INC. | 6.0 TO 6.5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |