FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 3963029
·
Received June 11, 2014
Report
- Report Number
- 1720753-2014-04908
- Event Type
- Malfunction
- Date Received
- June 11, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 11, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS ADVISED THAT THE COMPUTER FRU HAD TO BE REPLACED. THE CUSTOMER DECIDED TO CALL BACK LATER. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 345519 | ITRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |