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

Model Number 10742326

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

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

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction and adverse event occurred while operating the somatom force ct system.Siemens was notified that an 11 year old female patient needed to be rescanned due to image ring artifacts.As we consider children as a vulnerable patient group, this report is filed in the abundance of caution.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.A siemens service engineer went onsite and conducted a full evaluation of the system.Detector modules and channels were checked and found to be in good conditions.A visual inspection showed some contrast media drops on the detector.The detector was cleaned; and the sealing ring was treated with lubricant according to the documented maintenance instructions for regular service.No parts have been exchanged and the system was returned to regular operation.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system and no systematic or design issue was identified.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16223626
• MDR Text Key: 307891502
• Report Number: 3004977335-2023-59202
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR
• Patient Sex: Female