FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 3832589
·
Received March 27, 2014
Report
- Report Number
- 1720753-2014-02739
- Event Type
- Malfunction
- Date Received
- March 27, 2014
- Date of Event
- March 4, 2014
- Report Date
- March 27, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE S-RAM CARD AND SCSI CONTROLLER WERE EVALUATED AND REPLACED. THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO PROPERLY SAVE AND RECALL PT IMAGE DATA. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179451 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |