FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 3101732
·
Received April 30, 2013
Report
- Report Number
- 1720753-2013-05498
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 30, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND RELOADED SYS SOFTWARE AND CALIBRATION FILES. THE SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS WOULD LOCK UP WHILE ATTEMPTING TO SEND IMAGES TO DICOM/PACS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188173 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |