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

Model Number	10742326
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a ct scan using the somatom force system aborted during a turbo flash spiral investigation of a one-year-old patient.The user did not rescan the patient to avoid an additional x-ray dose and rescheduled the patient to undergo an mri (magnetic resonance imaging).The patient had been sedated during the scanning procedures.After the mri scan, the patient was brought to the surgery room.No negative health consequences were reported for the patient in association with the reported event.This report has been submitted with an abundance of caution.The reported event occurred in germany.
Additional Manufacturer Narrative
The event was reported by a siemens customer service engineer.A direct facility contact name was not provided.Siemens completed the technical investigation of the reported event.A data transmission failure between dms b (data measurement system, b-site) and irs (image reconstruction system) was identified.The transmitter b2 showed increased errors as soon as data was transmitted during rotation.The service engineer repaired the system by replacing the malfunctioning transmitter unit.A general product issue was not identified.Remedial action is not deemed necessary.The material consumption in relation to the installed base is monitored by the capa process.Values for the last 3 months for material number 10183874 - tx module rotation are: may 2022: 0.1%, april 2022: 0.22%, march 2022: 0.22%.No further investigation within the complaint process is necessary.The complaint will be closed.

• 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.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14986977
• Report Number: 3004977335-2022-33084
• Device Sequence Number: 1737439
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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: 06/21/2022
• Initial Report FDA Received Date: 07/12/2022
• 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: 1 YR
• Patient Sex: Female
• Patient Weight: 10 KG