FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2092456
·
Received May 2, 2011
Report
- Report Number
- 1720753-2011-06836
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 12, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS ADVISED TO LOAD THE CORRECT DATA. NO FURTHER INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTA TRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | INSTATRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |