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

Model Number	11330001
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that the ct scan aborted during a non-contrast chest examination of a (b)(6) patient.The user rescanned the patient using a different scanner and completed the examination.Other than the additional x-ray dose due to the second scan, no patient injury was reported to siemens associated with the reported event.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Initial reporter is a siemens employee.A contact name for the facility was not provided.Siemens completed the technical investigation of the reported event.The investigation revealed a sporadic problem with the tilt sensor due to the system vibrating at high rotation speeds.Therefore, a new revision of this tilt sensor will be introduced to improve the measurement stability by supplementing internal filters.The required changes are completely covered by the internal sensor firmware; therefore, no hardware change is necessary.This improvement is not a subject of a recall action.The material consumption in relation to the installed base is monitored by the capa process.Please see the following values for the last 3 months: material number: 11250701 - tilt sensor spare part kits - january 2022: 0.81 percent, december 2021: 0 percent, november 2021: 0 percent.

• Brand Name: SOMATOM X.CITE
• 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: 13693803
• Report Number: 3004977335-2022-16259
• Device Sequence Number: 19318618
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211373
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 11330001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• 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: 5 YR
• Patient Sex: Female