FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2042975
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02846
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 25, 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
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO REPRODUCE THE ISSUE. THE MONITOR WAS REPLACED PER THE CUSTOMER'S REQUEST. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9800 SYSTEM MONITOR WAS BLACK. 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 |