FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 1993058
·
Received February 8, 2011
Report
- Report Number
- 9680959-2011-00304
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- November 30, 2010
- Report Date
- February 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. A PIN WAS REPLACED IN THE CAMERA CONNECTION. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM EMITTED SMOKE ODOR AND THEREBY THE OPERATOR SHUT DOWN THE SYSTEM. NO REPORT OF PATIENT OR STAFF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |