FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2041399
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02719
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE POWER SUPPLY OUTPUT CONNECTION WAS REPAIRED AND THE HIGH VOLTAGE CONTROL PCB'S WERE RESEATED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN X-RAY ON ERROR MESSAGE WAS DISPLAYED ON THE 6800 SYSTEM. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |