FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2771768
·
Received October 2, 2012
Report
- Report Number
- 1720753-2012-07829
- Event Type
- Malfunction
- Date Received
- October 2, 2012
- Date of Event
- September 12, 2012
- Report Date
- October 2, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. HOWEVER, THE SERVICE REPRESENTATIVE REPLACED THE HARD DRIVE AND RELOADED THE SYSTEM SOFTWARE AS A PRECAUTIONARY MEASURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |