FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1133689
·
Received August 20, 2008
Report
- Report Number
- 1720753-2008-24782
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE BRAKE NEEDED TO BE REPLACED. THIS SYSTEM IS A DEMO UNIT AND IT IS ANTICIPATED THE REPLACEMENT OF THE BRAKE WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE C BRAKE IS BROKEN. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |