MAUDE Adverse Event Report: 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	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that an infant patient had to undergo a second topogram scan (low dose overview scan) due to a system malfunction during the use of the reported somatom definition flash system.Aside from the additional x-ray dose, there was no report of adverse event or injury sustained by the patient due to the necessity of the second scan.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 reported issue was attributed to, and was resolved by, replacement of the following parts: cu rot - pn / 10183882.Tx module rotation - pn / 10183874.Rx module rot - pn / 10183880.After replacement of the listed parts, the system was brought back to clinical operation.(b)(4).No general product design issue has been identified.Further investigation within the complaint process is not deemed necessary.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12561696
• Report Number: 3004977335-2021-96067
• Device Sequence Number: 1415700
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: 09/06/2021
• Initial Report FDA Received Date: 10/01/2021
• 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: 29 DA
• Patient Weight: 4