FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2062140
·
Received April 6, 2011
Report
- Report Number
- 9617766-2011-00822
- 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 GE REP CONDUCTED AN ONSITE INVESTIGATION. THE BUMPER ON THE RADIATOR HOUSING WAS REPLACED AND THE COLLIMATOR WAS ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 8800 SYSTEM DISPLAYED AN IRIS POTENTIOMETER ERROR MESSAGE. 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 |