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

Model Number 10590000

Device Problem Computer Software Problem (1112)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported to siemens that an adverse event and malfunction occurred while operating the somatom definition edge ct system.On (b)(6)2022, a scan was performed on a pediatric male patient.The customer reported that the user interface of the scanner was not responding after the topogram (low dose overview scan).As a result, the patient was rescanned on another ct system.Beside the additional x-ray dose, no other injury was reported.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a software error.The application freezes because the csapixelframe object of the topogram image is deleted while the image is released from the image processing toolkit (ipt) server and the image is still being processed in the background.After reboot of the system, the functionality recovers.This identified software issue has already been resolved with the service pack vb20_sp6 and released for distribution with ct014/22/s update vb20_sp6 on (b)(6)2022.This system is adressed for the update.

• Brand Name: SOMATOM DEFINITION EDGE
• 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: 15959004
• MDR Text Key: 308175916
• Report Number: 3004977335-2022-52989
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/12/2022

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: 11/14/2022
• Initial Date FDA Received: 12/12/2022
• 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
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 20 KG