FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4142919
·
Received September 12, 2014
Report
- Report Number
- 1720753-2014-07860
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- August 29, 2014
- Report Date
- September 12, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE IMAGE INTENSIFIER POWER SUPPLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS NOT DISPLAYED ON THE LEFT "LIVE" MONITOR. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565395 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |