FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2062306
·
Received April 12, 2011
Report
- Report Number
- 1720753-2011-03535
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- January 26, 2011
- Report Date
- April 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE INTERFACE BOARD AND THE EMERGENCY BUTTON NEEDED TO BE REPLACED. NO FURTHER REPAIR INFO IS AVAILABLE. THE SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE IMAGE ON THE 9600 SYSTEM COULD NOT BE SEEN CLEARLY WHILE IN SUBTRACTION MODE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |