FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2072438
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03476
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SYSTEM SOFTWARE AND CUSTOMER'S DATA WERE RELOADED. THE INTERFACE CABLE ASSEMBLY, INTERCONNECT CABLE AND MAINFRAME POWER SUPPLY WERE REPLACED AND ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD LOSE POWER. 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 |