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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 728306
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).
 
Event Description
The customer reported the ct box had noise.A philips field service engineer reported the microphone in the gantry was broken; the operator could not hear the patient.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.
 
Manufacturer Narrative
The customer reported that the microphone in the gantry was broken and the operator could not hear the patient from the scan room.This issue occurred on a brilliance ict system.The customer confirmed with the philips help desk (when this issue was reported) that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site and evaluated the system and determined the microphone in the gantry had failed.The fse replaced the breathing light assembly, which contains the gantry microphone, 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.
 
Manufacturer Narrative
The customer reported that the microphone in the gantry was broken and the operator could not hear the patient from the scan room.This issue occurred on a brilliance ict system.The customer confirmed with the philips help desk (when this issue was reported) that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site and evaluated the system and determined the microphone in the gantry had failed.The fse replaced the breathing light assembly, which contains the gantry microphone, 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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Brand Name
ICT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 miner rd
cleveland OH 44143
MDR Report Key7148982
MDR Text Key95963514
Report Number1525965-2017-00158
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K060937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number728306
Device Catalogue NumberNCTC780
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/04/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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