FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2153547
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08352
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE BATTERY WAS ADJUSTED. THE CONNECTORS ON THE FLUORO FUNCTIONS BOARD AND THE GENERATOR INTERFACE BOARD WERE CLEANED AND RESEATED. THE SYSTEM INTERFACE BOARD AND THE HIGH VOLTAGE CABLE WERE CHECKED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR ON THE SYSTEM WENT BLACK DURING A 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 |