FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2021879
·
Received February 25, 2011
Report
- Report Number
- 1720753-2011-01690
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY WAS REPLACED, THE XRAY CIRCUIT BOARD WAS RESEATED, AND THE KILOVOLTS WERE RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM IMAGE SCREEN WENT TO BLACK INSTEAD OF DISPLAYING AN IMAGE. 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 |