FDA Adverse Event
Malfunction
Summary report: N
4 X INTELLISPACE PACS SOLUTION
MDR report key: 3210218
·
Received June 27, 2013
Report
- Report Number
- 2954704-2013-00001
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- May 29, 2013
- Manufacturer
- PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS
- Product Code
- LLZ
- PMA / PMN Number
- K111804
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A PT MISMATCH BETWEEN REPORT DICTATION IN 3RD PARTY RIS AND IMAGES DISPLAYED IN INTELLISPACE PACS. THIS BEHAVIOR OCCURRED ONE TIME AND IS NOT REPRODUCIBLE. NO HEALTH RISK ISSUE WITH INTELLISPACE PACS HAS BEEN IDENTIFIED. THERE HAVE BEEN NO REPORTS OF HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293313 | 4 X INTELLISPACE PACS SOLUTION | LLZ | PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS | 835043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |