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

Model Number	11330003
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004977335-2023-66274
• Device Sequence Number: 17952931
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11330003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male