FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1980133
·
Received January 24, 2011
Report
- Report Number
- 9617766-2011-00109
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 24, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND PERFORMED A COLLIMATOR CALIBRATION. SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A "COLLIMATOR IRIS TOO LARGE" ERROR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |