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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS MEDICAL SOLUTIONS USA, INC SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 10430603
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Decrease in Pressure (1490); Retraction Problem (1536); Device Inoperable (1663); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2016
Event Type  malfunction  
Event Description
Patient at er for chest pains and sent for ct scan.Ct shut off during scanning and tech could not release table.Patient was able to crawl out of device unharmed.Scanning was not finished.Radiologist was able to obtain a calcium scoring from images that were completed.Service technicians responded and able to reboot ct.Tech found low oil pressure in tube a.Tube and heat exchanger replaced.Device was current on manufacturer preventative maintenance schedule.
 
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Brand Name
SOMATOM DEFINITION FLASH
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC
810 innovation dr.
knoxville TN 37932
MDR Report Key6092519
MDR Text Key59633838
Report Number6092519
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/19/2016
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 Other
Device Model Number10430603
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2016
Event Location Hospital
Date Report to Manufacturer09/19/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2016
Type of Device Usage N
Patient Sequence Number1
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