FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2243692
·
Received August 24, 2011
Report
- Report Number
- 1720753-2011-21335
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 18, 2011
- Report Date
- August 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE FORMATTED THE HARD DRIVE AND CINE DRIVE, RELOADED SOFTWARE, CONFIGURED FILES AND RESEATED THE WORK STATION PRINTED CIRCUIT BOARDS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO RUN A CINE LOOP DURING AN OPERATING ROOM PROCEDURE. NO PATIENT INJURY WAS REPORTED.
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 |