FDA Adverse Event
Malfunction
Summary report: N
C-ARM
MDR report key: 1812053
·
Received August 17, 2010
Report
- Report Number
- 9680959-2010-00281
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Date of Event
- June 21, 2010
- Report Date
- August 17, 2010
- 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. THE HARD DRIVE AND LASER AIMER WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE DEVICE FAILED TO BOOT AND THE LASER CENTERING DEVICE FAILED TO OPERATE PROPERLY. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-ARM | FLUOROSCOPY XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |