FDA Adverse Event
Other
Summary report: N
ISITE PACS
MDR report key: 1440663
·
Received August 13, 2009
Report
- Report Number
- 2954704-2009-00015
- Event Type
- Other
- Date Received
- August 13, 2009
- Date of Event
- July 17, 2009
- Report Date
- July 17, 2009
- Manufacturer
- PHILIPS HEALTHCARE INFO, INC
- Product Code
- LLZ
- PMA / PMN Number
- K063267
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
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 THAT TRANSFER OF IMAGES FOR (B)(6) PT FROM MODALITY TO PACS TOOK MORE THAN AN HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISITE PACS | ISITE PACS | LLZ | PHILIPS HEALTHCARE INFO, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |