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

Model Number	10742326
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported weight of the patient is (b)(6).Siemens has initiated a technical investigation of the reported event.A supplemental report will be submitted upon its completion.
Event or Problem Description
It was reported to siemens that a non- contrast ct scan of a (b)(6) patient had to be repeated.A communication failure suddenly occurred during the delayed phase countdown in a multi-phase scan.Aside from the additional x-ray dose administered to the patient during the successfully completed second scan, no patient injury has been reported to siemens.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The technical investigation revealed an internal error in the irs (image reconstruction system).One thread in the cuda context seems to hang.It may be during a cuda copy operation or a synchronization issue.Therefore, the irs did not send images in time to the ics (image control system).As no reboot was necessary to continue, any hardware problem is unlikely.The available files have been analyzed.The user has been advised to create a savelog (logfile collection including irs logs), get all dmp (dupmp) and trace files and a detailed description of the work flow (best would be a video sequence).This event was classified as a single event as it did not recur.The system was brought back to clinical operation by auto resuming.No general product issue could be identified based on available information, therefore no remedial action deemed necessary.

• Brand Name: SOMATOM FORCE
• 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-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 14219702
• Report Number: 3004977335-2020-24446
• Device Sequence Number: 4261557
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 10742326
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/06/2022
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 17 KG