FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092240
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06660
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE CONNECTOR IN THE POWER PLUG WAS TIGHTENED AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE FOOT PEDAL WAS USED ON THE 9900 SYSTEM THAT THE PREVIOUS IMAGE WOULD SHOW UP AND THE SCREEN WOULD GO BLACK. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |