FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2041478
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02745
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HIGH VOLTAGE CABLE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN TAKING AN INITIAL FLUORO SHOT TO DETERMINE LOCATION, IMAGE IS UPSIDE DOWN. THEY CORRECTED THE ORIENTATION AND THEN AFTER SEVERAL MINUTES, WHEN THE SHOT WAS THEN TAKEN AGAIN, THE IMAGE REVERTED BACK TO BEING UPSIDE DOWN. NO PT 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 |