FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2043423
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02907
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS ORDERED FOR THE CUSTOMER TO INSTALL. THE SYSTEM WAS TESTED AND ALL FUNCTIONS OPERATE AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM WAS PRODUCING AN INTERMITTENT DISTORTED LIVE IMAGE. NO PATIENT INJURY WAS REPORTED.
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 |