FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2062135
·
Received April 6, 2011
Report
- Report Number
- 9617766-2011-00816
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 10, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE COLLIMATOR WAS REPLACED AND ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS EVENT COULD BE A POSSIBLE ACCIDENTAL RADIATION OCCURENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A COLLIMATOR AND AN IRIS POTENTIOMETER ERROR MESSAGE ON THE 8800 SYSTEM, AFTER BOOTING UP. 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 |