FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2973897
·
Received February 19, 2013
Report
- Report Number
- 1720753-2013-01941
- Event Type
- Malfunction
- Date Received
- February 19, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 19, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND GENERAL PURPOSE OPERATING SYSTEM WERE REPLACED, AND THE SYSTEM SOFTWARE WAS UPGRADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS INTERMITTENTLY DISPLAYING ERROR MESSAGES AND LOCKING UP. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72673 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |