FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1002739
·
Received February 26, 2008
Report
- Report Number
- 9617766-2008-00108
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFORMATION PROVIDED, THE FOLLOWING COMPONENT HAS BEEN ORDERED. GENERATOR INTERFACE PCB. 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 FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PM INSPECTION, THE 8800 SYSTEM PRESENTED AN INTERMITTENT HV REGISTER FAILURE ERROR ON THE C-ARM. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | 8800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |