FDA Adverse Event
Malfunction
Summary report: N
NAVIGATION
MDR report key: 1731194
·
Received June 18, 2010
Report
- Report Number
- 1225258-2010-00004
- Event Type
- Malfunction
- Date Received
- June 18, 2010
- Date of Event
- May 26, 2010
- Report Date
- June 17, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (NAV)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM WAS INSPECTED. THE ENGINEER WAS ABLE TO TRACK WITH THE STRAIGHT AND FRENCH POINTERS AND ALSO THE DEBRIDER ATTACHMENT. THE FAILURE COULD NOT BE IDENTIFIED NOR DUPLICATED. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WAS NOT TRACKING WITH THE DEBRIDER ATTACHMENT. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVIGATION | RADIOLOGICAL IMAGE PROCESSING SYSTEM | LLZ | GE OEC MEDICAL SYSTEMS (NAV) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |