FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101790
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07134
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 21, 2011
- Report Date
- May 10, 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 SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP REPLACED THE LEFT MONITOR AND CLEANED AND REGREASED THE HIGH VOLTAGE CANDLESTICKS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT MONITOR WOULD LOSE THE LIVE IMAGE DURING FLUOROSCOPY. 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 |