FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 3060864
·
Received April 5, 2013
Report
- Report Number
- 1720753-2013-04652
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 20, 2013
- Report Date
- April 5, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CANCELLED THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM GOT HUNG UP (LOCKED UP) WHILE ATTEMPTING TO READ A PT SCAN CD. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139759 | ITRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |