FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 1011832
·
Received March 11, 2008
Report
- Report Number
- 1720753-2008-17882
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADD'L INFO AT THIS TIME. WHEN ADD'L INFO IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9400 SYS DISPLAYED A CRC DATA ERROR UPON INITIAL BOOT UP. IT WAS ALSO NOTED THAT THE SYS WOULD NOT BOOT AND THE FOOT PEDAL WAS NOT WORKING. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |