FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2092211
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06621
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM REMAINS DOWN. THE MFR PROVIDED THE CUSTOMER A REPAIR QUOTE. THE CUSTOMER WILL F/U REGARDING REPAIR APPROVAL. NO CONCLUSION CAN BE DRAWN AS 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 |