FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3000
MDR report key: 2103338
·
Received May 17, 2011
Report
- Report Number
- 1720753-2011-07391
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED TO CHECK THE ENVIRONMENTAL SETTINGS AND A SWITCH WAS RESET. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT AUTO BOOT ON REQUEST. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTA TRAK 3000 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | INSTA TRAK 3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |