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

Model Number 10742326

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/21/2022

Event Type  malfunction  

Event 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.

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
• 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.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14986977
• MDR Text Key: 295699937
• Report Number: 3004977335-2022-33084
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/12/2022
• 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: 1 YR
• Patient Sex: Female
• Patient Weight: 10 KG