FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4203087
·
Received September 18, 2014
Report
- Report Number
- 1720753-2014-07971
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 18, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE VOLTAGE ON PS1 WAS EVALUATED AND READJUSTED. 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 SCREEN TURNED BLANK AND THE SYSTEM WOULD TAKE AN EXPOSURE BY ITSELF. THIS IS CONSISTENT WITH A SYSTEM LOCK UP RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578899 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |