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

Model Number 11330003

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the naeotom alpha ct system.On (b)(6) 2023, a 6-year-old male patient underwent an inner ear examination in which the system hung up during the scan.As a result, a rescan of the patient was necessary.No negative health consequences were reported for the patient associated with the reported event.Therefore, this report is submitted with an abundance of caution as siemens considers children as a vulnerable patient group.

Manufacturer Narrative

H3, h6: siemens healthineers conducted a thorough investigation of the reported event.The root case was identified as a software bug, which will be solved within future software versions.The risk for this defect is rated as severity 2, probability a.Based on the technical and regulatory evaluation, this technical fix is deemed not reportable under 21 cfr 806.20 because it is not intended to reduce a risk to heath posed by the device or remedy a violation of the regulations caused by the device (which may present a risk to health).H7: inspection was checked in the initial report submitted on may 17, 2023.This selection was checked in error.

• Brand Name: NAEOTOM ALPHA
• 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 HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 8483234198
• MDR Report Key: 16950153
• MDR Text Key: 316291487
• Report Number: 3004977335-2023-71231
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K220814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11330003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• 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 YR
• Patient Sex: Male