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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS AG/SIEMENS HEALTHCARE GMBH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number CT-SENSATION 64 400-185419
Device Problem Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 05/16/2022
Event Type  malfunction  
Event Description
Ge was here to replace the mcu on this scanner, which is what was determined to be the culprit for why the scanner keeps cutting off mid-scan randomly.They replaced it and left; i went to scan an adrenal protocol on a patient that begins with a noncontrast scan of the abdomen and pelvis and the machine stopped after trying to acquire 1 image.I reloaded the scan and the machine stopped after a short series of images were acquired that only made it to the top of the patient's kidneys.At this time, i had to relocate the patient to our other scanner and call ge to come back to reevaluate this scanner as the problem is not fixed.At this moment they are here saying a controller is bad.The same area of interest/anatomy on this patient was irradiated 3 times in an effort to complete this scan.
 
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Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode 65-1a
malvern PA 19355
MDR Report Key14914291
MDR Text Key295248085
Report Number14914291
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 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberCT-SENSATION 64 400-185419
Device Lot NumberCE018943
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/23/2022
Event Location Hospital
Date Report to Manufacturer07/05/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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