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

Model Number 10742326

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom force ct system.The user reported that the phs (patient table) did not move to the scanning start position after a topo scan (low dose overview scan).As a result, the male pediatric patient, who is less than one year in age, was scanned again on another ct system.It was reported that the patient is in good health and we are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.A defective sp-wire-sensor has been identified and replaced.No general product issue could be identified.This report has been submitted with an abundance of caution.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 14591568
• MDR Text Key: 293265405
• Report Number: 3004977335-2022-27639
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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
• Date Manufacturer Received: 05/11/2022
• 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 Age: 6 MO
• Patient Sex: Male