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

Model Number 10742326

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported to siemens that a (b)(6) child needed to be re-scanned due to a somatom force software freeze.After the forced shutdown and restart, the scanner was fully operational again and the procedure was completed.Aside from the additional x-ray dose for the additional scan, no negative patient health effects were reported.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 performed a technical investigation of the reported incident; however, the request system log files could not be provided by the customer, therefore, a root cause could not be determined, and the reported issue could not be reproduced.Siemens requested the necessary data from the customer to complete an investigation if the issue reoccurs.Remedial action was not deemed necessary.

• 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.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 13078303
• MDR Text Key: 285757564
• Report Number: 3004977335-2021-07496
• 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
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 12/01/2021
• 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: 2 YR
• Patient Sex: Male
• Patient Weight: 10 KG