FDA Adverse Event
Malfunction
Summary report: N
ETRAK PLUS
MDR report key: 2031308
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02439
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- December 16, 2010
- Report Date
- March 16, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE LUCAS TRACKER COMPUTER. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A "TRACKER INACTIVE" ERROR MESSAGE AND DID NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETRAK PLUS | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ENTRAK 2500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |