FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1992005
·
Received February 4, 2011
Report
- Report Number
- 1720753-2011-00863
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 16, 2011
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE COLLIMATOR CLOSED UP WHEN THE CASSETTE WAS PLACED IN THE 2600 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |