FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2030579
·
Received March 9, 2011
Report
- Report Number
- 1720753-2011-02088
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 23, 2011
- Report Date
- March 9, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM, WATCHED IT DURING SURGERY AND WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE CUSTOMER REPORTED THAT REBOOTING THE SYSTEM HAD FIXED THE PROBLEM. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE COLLIMATOR CLOSED DURING FLUOROSCOPY, AND SQUARES APPEARED ON THE C-ARM DISPLAY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |