FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2100821
·
Received May 12, 2011
Report
- Report Number
- 1720753-2011-07283
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED AND THE REAL TIME OPERATING SYSTEM AND GENERAL PURPOSE OPERATING SYSTEM CENTRAL PROCESSING UNIT PRINTED CIRCUIT BOARDS AND THEIR CONNECTIONS WERE RESEATED IN THE WORKSTATION. 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 DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE. 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 |