MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10430603
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event.The root cause has not been identified and it is unclear if the system malfunctioned.A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported to siemens that during a contrast enhanced ct scan of a (b)(6)-month old infant with the somatom definition flash system, the scan aborted in the middle of the scan.The parent was standing next to the gantry during the examination, when this issue occurred.After a reboot of the scanner, the examination could be continued.Consequently, the child was rescanned, and additional 7 ml of contrast media was given.After the ct examination, a 4-hour saline drip needed to be given to the patient in order to flush contrast.No other injury of the patient has been reported except the additional xray dose, contrast media and need for the saline drip.This report has been submitted with an abundance of caution.
Additional Manufacturer Narrative
Siemens completed the technical investigation of the reported event.The root cause of the event was identified as a use error which was found by the siemens developer after investigating the event logfiles.The spiral scan after monitoring scans was aborted due to an incorrect htp position information in readings because patient table step plate, between the gantry and phs, was pressed.It was released approximately two minutes after the scan abort.No device malfunction has been identified.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10507425
• Report Number: 3004977335-2020-42304
• Device Sequence Number: 11511401
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 4