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

Model Number	10590000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's phone number is (b)(6).Siemens completed the technical investigation of the reported event.The artifacts were determined to be motion artifacts.Furthermore, the user had increased the scan speed (pitch) and rotation speed within the optimized default scan protocols for children, resulting in less projections during the scan.Therefore, the event is considered a user error.No general design issue was identified.No remedial actions will be initiated.
Event or Problem Description
It was reported to siemens that during a contrast enhanced ct chest scan of an 11-day old infant patient, blurry artifacts were observed on the ct image.The infant was sedated and intubated during the procedure.Due to the severe artifacts, a diagnosis was not possible.Afterwards, an ultrasound examination was required for the diagnosis.There were no negative health consequences to the infant reported to siemens with exception of the x-ray dose and contrast media administered without clinical benefit.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10818116
• Report Number: 3004977335-2020-51028
• Device Sequence Number: 19314273
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 10590000
• Device Catalogue Number: 10590000
• Device Lot Number: 83509
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial 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: 11 DA