FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4180681
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08649
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 15, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DISPLAY ADAPTOR BOARD WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM DID NOT DISPLAY AN IMAGE. THIS SITUATION IS A POTENTIAL HAZARD BECAUSE THE SYSTEM IS UNABLE TO DISPLAY A LIV IMAGE AND IS RENDERED INOPERABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATE WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654892 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |