FDA Adverse Event
Malfunction
Summary report: N
ENTRAK 2500
MDR report key: 3033135
·
Received April 1, 2013
Report
- Report Number
- 1720753-2013-04426
- Event Type
- Malfunction
- Date Received
- April 1, 2013
- Date of Event
- March 21, 2013
- Report Date
- April 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE CMOS AND UPS BATTERIES. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT NAV SYSTEM WOULD NOT BOOT. THIS CAN CAUSE A TOTAL LOSS OF NAVIGATION FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131550 | ENTRAK 2500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ENTRAK 2500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |