FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2031289
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02378
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE ERROR COULD NOT BE DUPLICATED AND NO SYSTEM FAILURE WAS FOUND. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SCREEN WENT BLANK AND NO IMAGE WAS PRODUCED ON THE 9800 SYSTEM. NO PT 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 |