FDA Adverse Event
Other
Summary report: N
ISITE PACS
MDR report key: 1504471
·
Received August 27, 2009
Report
- Report Number
- 2954704-2009-00017
- Event Type
- Other
- Date Received
- August 27, 2009
- Date of Event
- August 5, 2009
- Report Date
- August 5, 2009
- Manufacturer
- PHILIPS HEALTHCARE INFORMATICS, INC.
- Product Code
- LLZ
- PMA / PMN Number
- K063267
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ISITE PACS IS A SOFTWARE PRODUCT. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. BASED ON THE AVAILABLE INFO AT THE TIME OF THIS REPORT, WE CANNOT CONFIRM THAT THE DEVICE WAS A FACTOR IN THE INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER REPORTED A MIXUP OF IMAGES OF DIFFERENT PTS IN THE CANVAS PAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISITE PACS | ISITE PACS | LLZ | PHILIPS HEALTHCARE INFORMATICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |