FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2030501
·
Received March 9, 2011
Report
- Report Number
- 1720753-2011-02045
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 16, 2011
- Report Date
- March 9, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE MOTHER BOARD, FLOPPY DRIVES AND SRAM CARD WERE REPLACED. THE SYSTEM SOFTWARE WAS RELOADED AND THE SYSTEM WAS TESTED AND OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE C-ARM WILL NOT BOOT UP ON THE 9600 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |