FDA Adverse Event
Malfunction
Summary report: N
9600+
MDR report key: 1002740
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16412
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION AT THIS TIME. WHEN ADDITIONAL INFORMATION IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE IS NO IMAGE ON THE MONITOR OF THE 9600+ SYSTEM. IT WAS NOTED THAT ONLY STATIC LINES ARE DISPLAYED ON THE MONITOR WHEN THEY MAKE AN EXPOSURE. REBOOT WOULD NOT CLEAR THE PROBLEM. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600+ | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | 9600+ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |