FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2090524
·
Received April 26, 2011
Report
- Report Number
- 9680959-2011-01113
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 26, 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
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE LASER COVER AND THE PLASTIC COVER ON THE TUBE SIDE WERE REPLACED. THE EARTH CABLE WAS REPAIRED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE C-ARM CAP IS LOOSE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |