FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2072474
·
Received April 8, 2011
Report
- Report Number
- 9617766-2011-00886
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- February 2, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP EVALUATED THE SYSTEM AND FOUND THE HAND SWITCH WAS NOT OPERATIONAL. HE ORDERED THE HAND SWITCH AND PROVIDED IT TO THE CUSTOMER FOR REPAIR. THE SYSTEM NOW OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DOES NOT X-RAY AND IMAGES PERIODICALLY APPEAR BLACK. 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 (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |