FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2971162
·
Received February 1, 2013
Report
- Report Number
- 1720753-2013-01359
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 21, 2013
- Report Date
- February 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. THE SVC REP SUGGESTED THAT THE CUSTOMER FORMAT THE USB DRIVE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT LOCK UP WHILE ATTEMPTING TO SEND MESSAGE TO DICOM/PACKS. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45410 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |