FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1885071
·
Received October 20, 2010
Report
- Report Number
- 1720753-2010-03660
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- June 6, 2010
- Report Date
- October 20, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS CALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED AND WITHIN SPECIFICATIONS. THIS INCIDENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM'S DOSE WAS OUT OF CONFORMANCE. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPY XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |