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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS BRILLIANCE CT BIG BORE CT HPS1; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS BRILLIANCE CT BIG BORE CT HPS1; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 728244
Device Problems No Display/Image (1183); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 01/13/2022
Event Type  malfunction  
Event Description
The patients physician was there in the control during the procedure.The patient was scheduled for an abdomen/pelvis ct, but the patient became an rrt so they showed up at our exam room door.We adapted and performed the exam, but during the processing of the images the ct scanner computer shutdown causing the image process to stop which meant there were no images to look at causing a patient care delay.The computer eventually restarted and we were able to finish and have the images looked at by a radiologist.The gantry was power cycled which corrected the issue.
 
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Brand Name
PHILIPS BRILLIANCE CT BIG BORE CT HPS1
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
3721 valley centre drive, suite 500
san diego CA 92130
MDR Report Key13450795
MDR Text Key285065723
Report Number13450795
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number728244
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2022
Event Location Hospital
Date Report to Manufacturer02/04/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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