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 03/04/2023

Event Type  malfunction  

Manufacturer Narrative

During investigation of the event, a failure of the xtc (tube cooling unit) was identified.The service engineer repaired the system by replacing the malfunctioning xtc component.The system was brought back to clinical operation.The exchanged component was returned for further hardware investigation.Initial analysis has determined that the affected part was not exchanged within the past three months considering the whole installed basis and no other complaints exist regarding this component.A supplemental report will be provided if the hardware investigation shows any systematic or design issues.

Event Description

It was reported to siemens that a malfunction occurred while operating the neotoma alpha ct system.After a topo scan of a 3 year old male patient, when loading the next scan, the loading process was aborted with an error.The user restarted the ct system and repeated the topogram scan without success.The patient was then examined on another ct system.The patient was sedated during this procedure to perform the examination.No negative health consequences were reported for the child associated with the reported event.Therefore, this report has been submitted with an abundance of caution as siemens considers children as a vulnerable patient group.

• 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 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: 16573768
• MDR Text Key: 312196755
• Report Number: 3004977335-2023-66274
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K220814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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
• Date Manufacturer Received: 03/06/2023
• 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: 3 YR
• Patient Sex: Male