FDA Adverse Event
Injury
Summary report: N
CENTRICITY RA1000
MDR report key: 1085370
·
Received July 31, 2008
Report
- Report Number
- 3004526608-2008-00029
- Event Type
- Injury
- Date Received
- July 31, 2008
- Date of Event
- March 23, 2007
- Report Date
- April 12, 2007
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS DETERMINED THAT THE CUSTOMER INSTALLED CONFIGURATION DID NOT ADEQUATELY ADDRESS IMAGE DISPLAY REDUNDANCY. CUSTOMER COULD HAVE CONTINUED SURGERY BY: REVIEW FROM ANOTHER WORKSTATION, SENDING DIRECTLY TO VARIAN OR EXPORTING IMAGES TO CD MEDIA FOR VIEWING.
Description of Event or Problem · 1
DUE TO A COMMUNICATION ERROR BETWEEN THE PACS SYSTEM AND THE FACILITY'S VARIAN BRACHYVISION, A PROCEDURE HAD TO BE CANCELLED AND RESCHEDULED. THE SYSTEM WAS BEING USED FOR VIEWING IMAGES DURING A PROSTATE CARCINOMA TREATMENT PROCEDURE AT THE TIME WHEN THEY COULD NOT BE DISPLAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRICITY RA1000 | RA1000 | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | RA1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization | VARIAN| BRACHYVISION |