FDA Adverse Event
Other
Summary report: N
ISITE PACS
MDR report key: 1399763
·
Received June 4, 2009
Report
- Report Number
- 2954704-2009-00008
- Event Type
- Other
- Date Received
- June 4, 2009
- Date of Event
- May 7, 2009
- Report Date
- May 7, 2009
- Manufacturer
- PHILIPS HEALTHCARE INFORMATICS, INC.
- Product Code
- LLZ
- PMA / PMN Number
- K063267
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.
Description of Event or Problem · 1
NO REPORT OF PATIENT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED THE STUDY TIME AT REMOTE SITES IN TIME ZONES OTHER THAT THE ARCHIVE ARE INCORRECT.
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 |