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

Model Number	10742326
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed the investigation of the reported event.There was no device malfunction or design issue identified for the reported system.The root cause of the event was simply the patient's movement during the head scan resulting in the necessity of a second scan.Remedial action was not deemed necessary.Additional action was not deemed necessary.
Event or Problem Description
It was reported to siemens that during the head scan of a (b)(6) patient, the baby moved during the scan.The operator pressed the suspend button to stop the scan, then performed a second scan which was reported to good.The operator was unable to recon the first scan as the scan was too short.There were not enough rotations to acquire raw data for an image reconstruction.According to the hospital "the child is fine and suffered no ill effects" from the additional scan.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM FORCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 12883423
• Report Number: 3004977335-2021-05531
• Device Sequence Number: 14443438
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 16 MO
• Patient Sex: Female
• Patient Weight: 7 KG