FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2100336
·
Received May 13, 2011
Report
- Report Number
- 1720753-2011-07303
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 13, 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 FUSES WERE REPLACED. THE CALIBRATION FILES WERE RECEIVED AND LOADED. THE IMAGE INTENSIFIER NEEDS TO BE REPLACED. NO FURTHER SERVICE INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PREVIEW AND ORIENTATION WERE MISALIGNED. THIS HAPPENED PRIOR TO A CASE. ALSO, THE IMAGES WERE DIFFICULT TO VIEW WHEN THE LEAVES WERE COLLIMATED INTO VIEW DUE TO THE X-RAYS PENETRATING. NO PATIENT INJURY WAS 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 |