FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2043462
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02911
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD PRINTED CIRCUIT BOARD WAS REPLACED AND THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM WAS PRODUCING A 'COLLIMATOR CALIBRATION REQUIRED' ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |