FDA Adverse Event
Malfunction
Summary report: N
ETRAK 2500P
MDR report key: 1992928
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00977
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND DETERMINED THE COMPUTER NEEDED TO BE REPLACED. REPLACEMENT AND REPAIR HAVE NOT YET BEEN REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THEY WERE NOT ABLE TO LOAD A PT SCAN INTO THE NAV APPLICATION. THEY WERE ABLE TO CHOOSE THE PT SCAN, AND WHEN LOADING, THE SCAN STOPPED LOADING MID-WAY AND THE SYSTEM FROZE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETRAK 2500P | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ETRAK 2500P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |