FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2022311
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01780
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE TRANSFORMER WAS RESTRAPPED AND THE MONITORS VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEMS' TOUCHSCREEN LOCKED UP. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |