FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2170966
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08694
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND ATTEMPTED TO PERFORM MANUAL ANATOMIC REGISTRATION BUT THE CUSTOMER INDICATED TRACKING PERFORMANCE WAS NOT ACCEPTABLE FOLLOWING REGISTRATION AND MADE THE DECISION NOT TO RELY ON THE SYSTEM FOR THIS CASE. NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTA TRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | INSTATRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |