FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 958565
·
Received December 5, 2007
Report
- Report Number
- 1720753-2007-08325
- Event Type
- Malfunction
- Date Received
- December 5, 2007
- Date of Event
- November 14, 2007
- Report Date
- December 5, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. IDENTIFIED THE NEED TO REPLACE THE PNL PROCESSOR PCB AND THE CPP I/O PCB. THE REQUIRED PARTS HAVE BEEN ORDERED. ONCE REPLACED, IT IS BELIEVED THAT THE REPORTED ISSUE WILL BE ADDRESSED. IF ADDITIONAL INFO SHOULD INDICATE OTHERWISE A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMAGES WERE LOST WHEN USING THE 9600+ SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC | 9600+ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |