FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 3050529
·
Received April 8, 2013
Report
- Report Number
- 1720753-2013-04692
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 8, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS(SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE AND DIRECTED THEM IN PERFORMING A REPAIR OF THE BOOT UP SOFTWARE FOR THE SYSTEM. NO PT INJURY WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144288 | ITRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS(SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |