FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3792134
·
Received January 8, 2014
Report
- Report Number
- 1720753-2014-00270
- Event Type
- Malfunction
- Date Received
- January 8, 2014
- Date of Event
- December 20, 2013
- Report Date
- January 8, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR DRIVER PCB ASSEMBLY AND FILAMENT REGULATOR WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED ERRORS, AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12777 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |