FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2042941
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02838
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE PROBLEM. TWO CONTROL CABLES FROM THE ELECTROMAGNETIC INTERFERENCE (EMI) BOX TO THE VIDEO MONITORS WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED DURING A CASE BOTH MONITOR SCREENS WENT BLANK WHILE PERFORMING FLUORO. 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 |