FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 3060341
·
Received April 11, 2013
Report
- Report Number
- 1720753-2013-04869
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM BATTERY, XRC BATTERY AND SBC WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154487 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |