FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2153546
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08348
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE KEY SWITCH ASSEMBLY AND RESEATED THE PRINTED CIRCUIT BOARDS IN THE WORKSTATION. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PRODUCE FLUOROSCOPIC X-RAY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |