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9900 Adverse Event — Malfunction (MDR 1720753-2008-16308)

9900 Adverse Event — Malfunction (MDR 1720753-2008-16308) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 9900; Generic name: FLUOROSCOPIC X-RAY; Manufacturer: GE OEC MEDICAL SYSTEMS INC..

Device9900
Generic nameFLUOROSCOPIC X-RAY
ManufacturerGE OEC MEDICAL SYSTEMS INC.
Report number1720753-2008-16308
Event typeMalfunction
Product problemY
Date received2008-02-21
Report sourceHealth Professional, User facility
NarrativeIT WAS REPORTED THAT AFTER TAKING THREE FLUORO SHOTS WITH THE 9900 SYSTEM THE FORTH SHOT HAD A GREY AND TORN IMAGE AND THE MAINFRAME PRESENTED A COMMUNICATION FAILURE MESSAGE. THE SYSTEM WAS REBOOTED AND THE SAME THING HAPPENED. HOWEVER, THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT INJURY.
SourceopenFDA MAUDE (device adverse events)

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