FDA Adverse Event
Malfunction
Summary report: N
INSTATRAK 3500
MDR report key: 2023478
·
Received March 1, 2011
Report
- Report Number
- 1720753-2011-01737
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 1, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CIRCUIT BOARDS WERE REPLACED. THE CUSTOMER WAS ADVISED THE HARD DRIVE NEEDED REPLACE. THE CUSTOMER DECIDED NOT TO REPLACE THE HARD DRIVE ON THIS SYSTEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT UP AND THE MONITORS WERE BLANK. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTATRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | INSTATRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |