FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2153530
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08371
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REAL TIME OPERATING SYSTEM AND THE GENERAL PURPOSE OPERATING SYSTEM WERE REPLACED. ALL OF THE BOARDS AND CABLES WERE RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |