FDA Adverse Event
Malfunction
Summary report: N
CENTRICITY RA1000
MDR report key: 1220100
·
Received October 31, 2008
Report
- Report Number
- 3004526608-2008-00092
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 6, 2008
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT INFORMATION IN THE TITLE BAR AND IMAGES DISPLAYED ARE MATCHING CORRECTLY. HOWEVER, THE INDICATOR IN THE OPEN EXAM WINDOW IS POINTING TO THE INCORRECT EXAM. IT WAS REPORTED THAT WHEN THE SECOND SET OF IMAGES ARE OPENED, THE FIRST SET OF IMAGES REMAIN DISPLAYED AND THEREFORE IS MISLEADING TO THE USER. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRICITY RA1000 | PICTURE ARCHIVING & COMMUNICATION SYSTEM | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | RA1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |