FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2081001
·
Received April 14, 2011
Report
- Report Number
- 1720753-2011-03577
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- February 9, 2011
- Report Date
- April 14, 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 REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE OUTPUT DOSAGE TO WITHIN TOLERANCE AFTER CONFIRMING THE LOW LEVEL FLUOROSCOPY OUTPUT WAS 10.3R/MIN. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED IMAGE QUALITY PROBLEMS AND THE OUTPUT DOSAGE WAS OUT OF SPECIFICATION IN LOW LEVEL FLUOROSCOPY. 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 |