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

Model Number 10742326

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

It was reported to siemens healthineers that a malfunction occurred with the somatom force system.During an examination with a pediatric patient, communication between the gantry and the image reconstruction system (irs) was disrupted.Siemens is unaware whether the patient was rescanned following the occurrence.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 china.

Manufacturer Narrative

Siemens local service engineer inspected the concerned unit and resolved the issue by resetting the communication board in the irs.The system was brought back to normal operation.Internal id #: (b)(4).

• Brand Name: SOMATOM FORCE
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 15870934
• MDR Text Key: 304810214
• Report Number: 3004977335-2022-51471
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/28/2022
• 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 Outcome(s): Other