FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2100344
·
Received May 13, 2011
Report
- Report Number
- 1720753-2011-07307
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- February 17, 2011
- Report Date
- May 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE BEAM WAS REALIGNED AND THE BOARDS WERE RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND WAS PUT BACK INTO SERVICE. THIS EVENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S IMAGE WAS OF POOR QUALITY DURING A CASE. 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 |