FDA Adverse Event
Malfunction
Summary report: N
INSTATRAK 3500
MDR report key: 2092473
·
Received May 2, 2011
Report
- Report Number
- 1720753-2011-06837
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE UNINTERRUPTED POWER SUPPLY FAILED TO BOOT UP DUE TO THE INTERNAL GROUNDING PLATE NOT BEING INSTALLED TO THE COMPLETE BATTERY CIRCUIT. NO REPAIR INFO IS AVAILABLE AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
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 |