FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1001182
·
Received February 22, 2008
Report
- Report Number
- 1720753-2008-16373
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 22, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFORMATION PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. DARLINGTON DRIVER PCB, INVERTER DRIVER PCB, X-RAY REGULATOR PCB AND DARLINGTON XSTR. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT 2600 SYSTEM PRESENTS AN X-RAY OVERTIME ERROR WHEN TAKING FILM SHOTS. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |