FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2193525
·
Received July 21, 2011
Report
- Report Number
- 1720753-2011-20279
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE MONITOR CABLE AND THE 3V BATTERY WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A BIOS ERROR MESSAGE AND THE COLOR ON THE SCREEN WAS DEGRADED. 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 | INSTA TRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |