FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2072432
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03471
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 4, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CONNECTORS WERE RESEATED AND THE ELECTRICAL VOLTAGES WERE CHECKED. THE LEFT MONITOR WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER THE 9900 SYSTEM WAS BOOTED UP, THE MONITOR SCREEN WAS INTERMITTENTLY FLASHING. 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 |