FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2092446
·
Received May 2, 2011
Report
- Report Number
- 1720753-2011-06815
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 14, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. IT WAS EXPLAINED TO THE CUSTOMER HOW TO EXIT AFTER ANNOTATING A PT, HOW TO RECALL THE IMAGE AND SEND TO PACS. THE INFO WILL BE PROVIDED TO THE OTHER TECHNICIAN BY THE CUSTOMER. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT SEND ANNOTATION TO THE PACS SERVER CORRECTLY AND THAT SOMETIMES IT WOULD END UP ON THE WRONG IMAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |