MAUDE Adverse Event Report: SOMATOM DRIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10431700
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	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter name was not provided to siemens as of the date of this report and have been requested by siemens.A siemens employee reported the complaint to siemens.Siemens has initiated a technical investigation of the reported event.A root cause has not been identified.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to siemens that during a dual energy ct contrast scan of a (b)(6) male patient using the somatom drive system, the runoff scan could not be loaded after monitoring and the examination was aborted.The scan had to be repeated using a different ct system and additional contrast media was administered.The second low dose overview scan (topogram) was completed successfully.The patient did not suffer any adverse health issues due to the delay in the examination, additional low dose x-ray exposure and additional contrast media.This report has been submitted with an abundance of caution.
Additional Manufacturer Narrative
Siemens performed technical evaluation of the reported event and system.The issue was caused by the customized scan protocol "de_runoff", in dual energy spiral range "de runoff" with rottime 1.0s and coll.Slice 64x0.6.The range is based on siemens mode de_extrangio_bonerem_ir.Adult", which is designed with rottime 0.33s, coll.Slice 32x0.6.The scanner could not find the correct calibration table with the invalid parameter which resulted in the reported problem.This system behavior will be resolved in the next servicepack vb20a_sp5.A defect for follow-up in siemens change management has been opened.

• Brand Name: SOMATOM DRIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11640518
• Report Number: 3004977335-2021-72253
• Device Sequence Number: 3049289
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 10431700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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: 10 YR
• Patient Weight: 82