FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4180691
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08637
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 26, 2014
- Report Date
- October 15, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE WERE INSTALLED 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 THAT THE SYSTEM WAS NOT SAVING PATIENT IMAGES. AND THE SYSTEM WAS SLOW TO BOOT UP. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653124 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |