FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2243676
·
Received August 24, 2011
Report
- Report Number
- 1720753-2011-21334
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REFORMATTED THE CINE DRIVE AND RECALIBRATED THE COLLIMATOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY COULD NOT USE THE CINE DRIVE AND THEY THOUGHT IT WAS A SOFTWARE PROBLEM. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |