FDA Adverse Event
Malfunction
Summary report: N
CENTRICITY WEB
MDR report key: 1216359
·
Received October 29, 2008
Report
- Report Number
- 9681779-2008-00004
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- LLZ
- Removal / Correction Number
- 9681779-10/08/08-0001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CENTRICITY WEB (CWEB) EXPERIENCED A FORCED LOG OUT, WHILE BEING USED IN SURGERY. THE FORCED LOG OUT OCCURRED DUE TO A DEFECT CREATING THE CWEB FORCE OUT, RATHER THAN CWEB SESSION ENDING AT A USER PRE-SET TIME. CENTRICITY WEB IS INTENDED FOR IMAGE REVIEW AND NOT FOR DIAGNOSTIC USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRICITY WEB | ENTERPRISE WEB | LLZ | GE HEALTHCARE INTEGRATED IT SOLUTIONS | CENTRICITY WEB | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |