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Model Number 728306 |
Device Problem
Device Inoperable (1663)
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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.(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 the operator was not able to hear the patient during clinical use.If the operator is unable to hear the patient due to a failed microphone, 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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The customer reported on (b)(6) 2018 that the operator was not able to hear the patient from inside the scan room during clinical use of the ct system.The customer confirmed with the philips helpdesk (when this issue was reported) that there was no patient impact and no harm as a result of this event.On (b)(6) 2018, the philips field service engineer (fse) arrived at the customer site to evaluate the ct system.The fse found that the gantry microphone had failed and was causing a feedback noise through the speaker on the ct box.The fse replaced the breathing light assembly, microphone assembly- front lcd panel, and 4 channel gantry audio board to correct and resolve the issue.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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