FDA Adverse Event
Malfunction
Summary report: N
ETRAK 2500
MDR report key: 1992934
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00978
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE TRANSMITTER AND RECEIVER CABLES. THE GE REPRESENTATIVE ATTACHED THE RECEIVER TO THE HEAD PIECE AND ENERGIZED THE SYSTEM, SELECTED AN OLD PATIENT FILE AND STEPPED THROUGH THE CALIBRATION PROCESS WITH NO ERRORS. THIS WAS COMPLETED SEVERAL TIMES TO VERIFY PROPER SYSTEM OPERATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM TRACKING WAS OFF BY 3 TO 4 MILLIMETERS. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETRAK 2500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ETRAK 2500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |