FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1002664
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16390
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. GENERATOR INTERFACE PCB AND A FLUORO FUNCTION PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADD'L INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMAGE QUALITY ON THE 9800 SYSTEM IS POOR. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |