FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2030215
·
Received March 7, 2011
Report
- Report Number
- 1720753-2011-01966
- Event Type
- Malfunction
- Date Received
- March 7, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE SVC REP RELOADED THE SYSTEM SOFTWARE AND REFORMATTED THE HARD DRIVE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE IMAGES WERE NOT BEING SENT TO THE PT'S FILE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |