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

Model Number	10430603
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height was reported to be (b)(6).Exact patient weight is (b)(6).Siemens has initiated a technical investigation of the reported event.Siemens physics experts requested the raw dataset from the facility.A product design issue was not identified.A supplemental report will be provided if new information becomes available.
Event or Problem Description
It was reported to siemens that ct brain images of a 2-year-old patient were too dark to use.The patient had been brought to the facility emergency room due to lethargy.The siemens application specialist contacted the user but could not identify a general issue.With a second reconstruction the image quality was better, but the user decided to perform a second scan using a different ct scanner.The patient was asleep during both procedures.Aside from the additional x-ray dose, no injury to the patient was reported to siemens.This report was submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11715614
• Report Number: 3004977335-2021-75443
• Device Sequence Number: 14559769
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 04/23/2021

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): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 18