Model Number 8800 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 12/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A ge service representative performed an onsite investigation.The customer reported that the system intermittently was giving a secondary unintended exposure after the release of the hand switch.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 handswitch.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 investigation concluded the hand switch failed due to normal wear and tear, as the hand switch was greater than 9 years old.No further actions are planned by the manufacturer at this time.
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Search Alerts/Recalls
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