FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2202671
·
Received August 8, 2011
Report
- Report Number
- 1720753-2011-20820
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- June 20, 2011
- Report Date
- August 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR CONTROL BOARDS WERE RESEATED. 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 THAT THE SYSTEM'S FAST STOP SWITCH WAS ACTIVATED CAUSING AN UNCOMMANDED SHUT DOWN OF THE SYSTEM. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |