FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3871889
·
Received April 17, 2014
Report
- Report Number
- 1720753-2014-03376
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 17, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HV (HIGH VOLTAGE) CABLE AND FFB PCB ASSEMBLY WERE BOTH EVALUATED AND REPLACED. THE COLLIMATOR WAS SUCCESSFULLY CALIBRATED. 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'S COLLIMATOR WOULD NOT OPEN PREVENTING THE SYSTEM FROM DISPLAYING VISIBLE FLUOROSCOPIC EXPOSURES. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235948 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |