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

Model Number	10590000
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a siemens employee.A contact name for the facility was not provided.Siemens has initiated a detailed technical investigation of the reported event.A supplemental report will be filed upon its completion.
Event or Problem Description
It was reported to siemens after performing a polytrauma topogram scan of the skull, the user interface of the ct scanner froze during the polytrauma topogram of the (b)(6)-year-old patient's abdomen and pelvis.The patient was then unloaded from the reported ct scanner and the procedure was completed using a different scanner.After the application was restarted, the reconstructions from the first scan range (skull) for this patient could be performed.Aside from the additional x-ray dose from the second topogram, no patient injury associated with event was reported to siemens.The child was in good medical condition when released.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed the investigation of the reported event.The system was brought back to clinical operation after restart and was monitored for one month with enable traces (extended logging) without re-occurrence.No general product issue could be identified.The root cause could not be determined based on available information.In case of re-occurrence, the customer has been asked to provide all logfiles and date and time of occurrence.No remedial action is deemed to be necessary.

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13684011
• Report Number: 3004977335-2022-16496
• Device Sequence Number: 5985773
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 10590000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 20 KG