FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 3001862
·
Received February 12, 2013
Report
- Report Number
- 1720753-2013-01707
- Event Type
- Malfunction
- Date Received
- February 12, 2013
- Date of Event
- January 29, 2013
- Report Date
- February 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND DETERMINED THE BATTERIES NEEDED TO BE REPLACED. A QUOTE WAS GIVEN TO THE CUSTOMER. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.
Description of Event or Problem · 1
THE CUSTOMER AND FE REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. A GENERATOR ERROR MESSAGE IS LIKELY TO RESULT IN A SYSTEM LOCK UP OR SHUT DOWN SITUATION. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61337 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |