FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1070871
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-22835
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 24, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP TORQUED WORKSTATION TRANSFORMER NUT'S TO 60" LBS CHECKED ALL WORKSTATION FUSE AND FUSE HOLDER SWITCH SERVICE UP TO VERIFIED NO ERRORS ON BOOT-UP. BOOTED SYSTEM X 10 SYSTEM BOOTS WITHIN 165 SEC. SYSTEM CHECKED AND TESTED O.K.
Description of Event or Problem · 1
THE CUSTOMER REPORTED INTERMITTENT SLOW TO BOOT UP. NO PT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |