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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 Problems Signal Artifact/Noise (1036); Degraded (1153); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Improper Device Output (2953); Output Problem (3005)
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
Engineering analysis concluded that this event has the potential to result in image misinterpretation due to an artifact from a degraded compensator within the collimator.Therefore, this issue has been determined to be a reportable event.
 
Manufacturer Narrative
The customer reported intermittent artifacts on patient images.There was no report of misrepresentation as a result of the artifacts.A philips field service engineer (fse) confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of this reported issue.The fse confirmed that ring artifacts were present on scan images in the region of interest.The fse visually inspected the system and found a crack in the compensator of the a-plane collimator.The a-plane collimator was replaced and calibrations run to resolve the issue.The system was returned to clinical use.This issue has been determined not to be a reportable event.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.
 
Manufacturer Narrative
The device has been evaluated by the manufacturer.The report source was also updated.The customer reported intermittent artifacts on patient images.There was no report of misrepresentation as a result of the artifacts.A philips field service engineer (fse) confirmed there was no harm to a patient and no report of misrepresentation and/or mistreatment as a result of this reported issue.The fse confirmed that ring artifacts were present on scan images in the region of interest.The fse visually inspected the system and found a crack in the compensator of the a-plane collimator.The a-plane collimator was replaced and calibrations run to resolve the issue.The system was returned to clinical use.This issue has been determined not to be a reportable event.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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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
Manufacturer Contact
derrick massuri
595 miner rd
cleveland, OH 44143
4404833000
MDR Report Key7107491
MDR Text Key94644743
Report Number1525965-2017-00084
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number728306
Device Catalogue NumberNCTC780
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/17/2016
Initial Date FDA Received12/12/2017
Supplement Dates Manufacturer Received09/17/2016
Supplement Dates FDA Received07/13/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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