FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4203035
·
Received September 18, 2014
Report
- Report Number
- 1720753-2014-07984
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 27, 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 CONNECTORS WERE RESEATED AND THE POWER SUPPLY WAS ADJUSTED 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
THE CUSTOMER REPORTED THE SYSTEM CONTINUED UNCOMMANDED X-RAY AND HAD A CONTROL PANEL ERROR. THE FE STATED THE SYSTEM DID NOT PRODUCE UNCOMMANDED X-RAY, BUT CONTINUED TO BEEP AND LOCKED UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578974 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |