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

Model Number	10430603
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition flash ct system.It was reported to siemens that a child (1 year old) was rescanned on (b)(6) 2022.According to available information, the customer pressed the hold button after the topo scan (low dose overview scan) and error messages were displayed.The customer resolved the issue by restarting the ct system.The scan of the child could then be completed.No negative health consequences were reported for the child in association with the reported event.Necessary data for a detailed technical investigation was requested, however, no further information was provided.Based on the information available, no general product issue could be identified and the issue is rated as a single occurrence.This report has been submitted out of an abundance of caution.
Additional Manufacturer Narrative
Necessary data for a detailed technical investigation was requested, however, no further information was provided.Based on the information available, no general product issue could be identified and the issue is rated as a single occurrence.This report has been submitted out of an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15041986
• Report Number: 3004977335-2022-34290
• Device Sequence Number: 5224432
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Female