FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2884943
·
Received December 4, 2012
Report
- Report Number
- 1720753-2012-10053
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 13, 2012
- Report Date
- December 4, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE AND SYSTEM INTERFACE BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP CORRECTLY AND WAS DISPLAYING COMMUNICATION ERROR MESSAGES. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |