FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2093087
·
Received May 3, 2011
Report
- Report Number
- 1720753-2011-06877
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 14, 2011
- Report Date
- May 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE CABLING, CONNECTIONS, IMAGE INTENSIFIER, CAMERA, AND ERROR LOGS WERE CHECKED. HOWEVER, THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. HOWEVER, THE REMOTE TOUCH WAS UNABLE TO BE REPAIRED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S MONITOR INTERMITTENTLY WENT BLANK AND REQUIRED THE SYSTEM TO BE POWERED DOWN AND REBOOTED AND THE REMOTE TOUCH WOULD NOT WORK. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |