PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Device Problems
Device Operates Differently Than Expected (2913); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).
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Event Description
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The customer reported that there was noise in the speaker when speaking with the patient through the ct box.The philips field service engineer (fse) confirmed that the operator could only hear the patient intermittently due to the noise coming from the ct box speaker.If the operator is unable to hear the patient due to a failed microphone, there is potential for injury to the patient.This event is currently under investigation.
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Manufacturer Narrative
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The customer reported that the operator could only hear the patient intermittently due to the noise coming from the ct box speaker.The customer confirmed with the philips helpdesk that there was no patient impact and no harm as a result of this event.The philips field service engineer was dispatched to the customer site and evaluated the ct system and determined that there was noise in the speaker when the operator was speaking with patient through the ct box.The fse replaced the ct box assembly, gantry microphone assembly and speaker to correct and resolve the malfunction.The system is operational and in clinical use.Further investigation of this event has determined that it is not reportable.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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