FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2062098
·
Received April 6, 2011
Report
- Report Number
- 1720753-2011-03296
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. 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 9900 SYSTEM LOCKED UP WITH AN ERROR MESSAGE DURING A CASE. THE SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT 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 |