9600+ Adverse Event — Malfunction (MDR 1720753-2008-16307)
9600+ Adverse Event — Malfunction (MDR 1720753-2008-16307) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 9600+; Generic name: FLUOROSCOPIC X-RAY; Manufacturer: GE OEC MEDICAL SYSTEMS INC..
| Device | 9600+ |
|---|---|
| Generic name | FLUOROSCOPIC X-RAY |
| Manufacturer | GE OEC MEDICAL SYSTEMS INC. |
| Report number | 1720753-2008-16307 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Health Professional, User facility |
| Narrative | A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. HOWEVER, COMPLETED A CALIBRATION OF THE SYNC WHICH MAY HAVE CAUSED THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE. |
| Source | openFDA MAUDE (device adverse events) |
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