FDA Adverse Event
Malfunction
Summary report: N
CENTRICITY RA1000
MDR report key: 1220098
·
Received October 31, 2008
Report
- Report Number
- 3004526608-2008-00090
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 10, 2008
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN USING A MOUSE TO SCROLL THROUGH THE PATIENT JACKET PALETTE AND THEN USING THE MOUSE WHEEL DOUBLE CLICK IN THE WORK MODES PALETTE IN ORDER TO DISPLAY IN EXAM, A DIFFERENT EXAM WILL DISPLAY. THE RADIOLOGIST MAY NOT NOTICE THAT THE WRONG EXAM HAS DISPLAYED, WHICH COULD LEAD TO A POTENTIAL MISDIAGNOSIS. THERE WERE NO REPORTS OF ADVERSE EVENTS OR PATIENT INJURY REPORTED TO BE ASSOCIATED WITH THIS INCIDENT.
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 |