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

Model Number 11330001

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 288816758
• Report Number: 3004977335-2022-16259
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female