FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 916040
·
Received September 20, 2007
Report
- Report Number
- 1720753-2007-05917
- Event Type
- Malfunction
- Date Received
- September 20, 2007
- Date of Event
- September 3, 2007
- Report Date
- September 20, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND THE ATTACHED NAI DICOM BOX HAD THE POWER CORD UNPLUGGED AND WOULD NOT ALLOW SYSTEM POWER UP. A/C POWER CABLE WAS INSTALLED TO THE NAI DICOM BOX TO RESTORE FUNCTION. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PATIENT INFORMATION WITH RESPECT TO THIS ISSUE. NO PATIENT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.
Description of Event or Problem · 1
THE GE OEC 9600 FLUOROSCOPY SYSTEM WOULD NOT BOOT UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9600 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |