FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2022904
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01635
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- November 30, 2010
- Report Date
- February 24, 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
A GE REP PERFORMED AN ON SITE INVESTIGATION. THE CIRCUIT BOARD CONTACTS WERE CLEANED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED WHEN USING THE XRAY EMISSION CONTROL THE IMAGE ON THE MONITOR IS BLACK AND SOMETIMES THE IMAGE DISAPPEARED FROM THE MONITOR. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |