FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2063064
·
Received March 21, 2011
Report
- Report Number
- 1720753-2011-02590
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON SITE INVESTIGATION, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR ON THE 9800 SYSTEM WOULD GO BLANK. 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 |