FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2100247
·
Received May 16, 2011
Report
- Report Number
- 1720753-2011-07360
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CMOS BATTERY NEEDS TO BE REPLACED. IT IS ANTICIPATED THAT THE REPRESENTATIVE WILL ORDER AND REPLACE THE BATTERY AND THAT THIS WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE REGARDING THE CMOS BATTERY AND THERE WAS AN ISSUE REGARDING THE DATE AND TIME. 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) | INSTA TRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |