FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2021587
·
Received February 21, 2011
Report
- Report Number
- 1720753-2011-01516
- Event Type
- Malfunction
- Date Received
- February 21, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS FOUND TO BE DAMAGED DURING THE SERVICE CALL. THE CUSTOMER CANCELED THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM HAD A COLLIMATOR IRIS POTENTIOMETER ERROR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |