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

Model Number	10742326
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a technical investigation.The second scan was suspended by the user which resulted in the scan being technically too short for reconstruction as the scan length was smaller than one physical detector width.No general design issue has been identified at this time.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom force ct system.On (b)(6) 2021, a (b)(6)-month-old female patient was scanned on the somatom force ct scanner.During the cranial ct scan, the patient moved, and the scan did not cover the required anatomical structure.A short scan needed to be repeated, however, the second scan was suspended by the user which resulted in the scan being technically too short for reconstruction as the scan length was smaller than one physical detector width.The child was not scanned a third time.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens completed a detailed technical investigation of the reported event.As previously reported, the second scan was suspended by the user resulting in the scan being technically too short for reconstruction.The scan length was smaller than one physical detector width.The root cause of the reported issue is user error.Siemens confirmed that there was no device malfunction and there were no general design issues.Further investigation is not warranted at this time.This report has been filed with an abundance of caution.

• Brand Name: SOMATOM FORCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11997830
• Report Number: 3004977335-2021-81866
• Device Sequence Number: 1100231
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 10742326
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 06/18/2021
• 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