FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101787
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07137
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 25, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE LEFT MONITOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOSE THE LIVE IMAGE ON THE LEFT MONITOR DURING FLUOROSCOPIC X-RAY. 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 |