FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101601
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07181
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 27, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD, THE BACKPLANE, AND THE SYSTEM INTERFACE BOARD WERE REPLACED. THE SYSTEM DRIVE WAS FORMATTED AND RELOADED AND THE CONTACTS ON THE POWER SUPPLY WERE CLEANED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR MESSAGE AND A GENERATOR INTERFACE BOARD ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |