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

Model Number	10430603
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that a malfunction occurred prior to operating the somatom definition flash ct system.On (b)(6) 2002, two children (15 months and 7 years) were planned for examination.A system malfunction occurred and the examination could not be performed.The siemens service engineer checked the system onsite and found two defective fuses on the pdr component (power distribution rotating) and replaced them.Further checks were performed, and a defective tube was also identified.The tube was replaced on (b)(6) 2022, and the system was brought back to clinical operation.According to information received, both patients were rescanned and are in good health condition.No negative health consequences were reported for the children associated with the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The material consumption in relation to the installed base is monitored by our capa process.The consumption for the affected component on this specific system is normal and within defined thresholds.No further investigation within the complaint process is necessary.Based on the information available, no general product design issue could be identified, and no further measures are required.This issue is rated as a service case.Therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: 15392235
• Report Number: 3004977335-2022-42881
• Device Sequence Number: 6463780
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/09/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Unknown