PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Model Number 728323 |
Device Problem
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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Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).
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Event Description
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This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that there was noise from the ct box speaker due to gantry electronics/fan sounds without any input from the microphone; therefore, the speaker volume was turned down.If the operator is unable to hear the patient due to the volume being turned down to a minimum, there is potential for injury to the patient.This issue has been determined to be a reportable event.This event is currently under investigation.
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Manufacturer Narrative
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On (b)(6) 2017, the customer reported there was noise coming from the ct box speaker.The customer confirmed that they were able to hear the patient¿s voice through the ct box over the background noise, and there was no harm to a patient, operator or bystander as a result of this event.A philips field service engineer (fse) evaluated the ct system and determined that the 4 channel gantry audio board had failed.The fse replaced the 4 channel gantry audio board and the issue was resolved.The system is operational and in clinical use.This event has been determined not to be a reportable event.
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Search Alerts/Recalls
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