FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2100253
·
Received May 16, 2011
Report
- Report Number
- 1720753-2011-07361
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 6, 2011
- Report Date
- May 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED ON HOW TO REBOOT THE SYSTEM. THE SYSTEM DID REBOOT AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP AND DISPLAYED A MESSAGE REQUESTING THAT A SYSTEM DISK BE INSERTED. 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) | INSTA TRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |