Model Number 9900 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 12/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A ge service representative performed an onsite investigation.The customer reported a brief unintended fluoroscopic x-ray exposure after the switch was released.The reported issue could not be duplicated.The hand switch x-ray controller was replaced during the service event.A supplemental report will be submitted at the conclusion of the investigation which was opened related to the events surrounding this complaint.
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Event Description
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The customer reported that fluoroscopic x-ray stays on after releasing the hand switch.This event may have resulted in an aro (accidental radiation occurrence).No patient death or serious injury was reported related to this event.
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Manufacturer Narrative
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A root cause investigation was completed related to the reported event.The customers reported issue could not be duplicated.Subsequent analysis of the hand switch found no evidence of a malfunction.Analysis of the shot log file data also found no likely evidence to indicate the switch failed to perform as intended.The hand switch was 9 years old, however performed without failure during component testing.The investigation concluded that no root cause could be identified related to this event.No further actions are planned by the manufacturer at this time.
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Search Alerts/Recalls
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