FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3231045
·
Received July 12, 2013
Report
- Report Number
- 1720753-2013-08078
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 12, 2013
- Report Date
- July 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR DRIVER BOARD WAS DETERMINED TO BE DEFECTIVE. THE CUSTOMER PLANNED TO ORDER THE REPLACEMENT PART AND INSTALL IT THEMSELVES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CINE SUBTRACTION ERROR MESSAGE THAT CAUSED THE SYSTEM TO LOCK UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321741 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |