FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2090047
·
Received April 11, 2011
Report
- Report Number
- 1720753-2011-03516
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE SPOKE TO THE CUSTOMER OVER THE PHONE AND FIXED THE REPORTED PROBLEM. NO ADDITIONAL SERVICE DETAILS WERE PROVIDED. THE SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM WOULD NOT DISPLAY AN IMAGE. NO PATIENT 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 |