FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4203038
·
Received September 18, 2014
Report
- Report Number
- 1720753-2014-07982
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 20, 2014
- Report Date
- September 18, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD AND THE GENERATOR INTERFACE BOARD WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM HAD A DATA ERROR AND LOCKED UP. THIS CAUSED AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN A PROCEDURAL DELAY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578975 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |