FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2092227
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06643
- 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REP REPLACED THE HIGH VOLTAGE CABLE, THE BRAKE HANDLE, THE KEYPAD EXTENSION, SINGLE BOARD COMPUTER CIRCUIT BOARD, AND THE SINGLE BOARD COMPUTER COIN BATTERY. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM MONITORS WOULD NOT TURN ON AND FRAYED CABLES WERE FOUND. NO PT 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 |