FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2092193
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06627
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS THE CUSTOMER CANCELLED THE SERVICE CALL AND REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9600 SYSTEM DISPLAYED A PRECHARGE ERROR MESSAGE. NO PT 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 |