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

Model Number 10590000

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Code Available (3191)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Although there was no serious injury to the patient, there was a 60 minute delay in diagnosis.Siemens has initiated an investigation of the reported event.The issue is still under investigation.A supplemental report will be provided upon its completion.

Event Description

It was reported to siemens that during a ct examination of a sedated, (b)(6) trauma patient, reconstruction of fast-spine images was delayed for 60-minutes.The user interface did not react.The image reconstruction was possible after 60-minutes without an additional x-ray dose to the patient.Nevertheless, an emergency diagnose is possible with 2d transversal images.No patient injury was reported to siemens and the patient did not suffer any negative health consequences due to this issue.This event has been reported with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Additional information.Siemens is planning to resolve the reported software issue with a new service pack software version vb20_sp3.This update will be reported as a fsca in accordance wtih 21 cfr 806 and will be reported separately to the fda.

Manufacturer Narrative

Siemens has completed the technical investigation of the reported event.The root cause was determined to be attributed to a software issue (version vb20a_sp1).The issue occurs during the handling of images loaded to the image processing toolkit (ipt) server from different components is done independently.This can lead to errors when the image is deleted by one component although it is being used by another at the same time.This can result in the display of black images or errors during loading of the protocol version.After the system is rebooted, the system functionality recovers.

• Brand Name: SOMATOM DEFINITION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10206220
• MDR Text Key: 196771136
• Report Number: 3004977335-2020-32409
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 10/20/2020
• Supplement Dates FDA Received: 11/05/2020; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR