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

Model Number	10430603
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As result of the technical investigation the following root cause has been identified: the negative ctdiweffective is caused by carekv-group-feature.Mlmoveablefilter2bodywedge incorrectly copied within carekv group leading to negative ctdi.This defect violates the applicable technical standards for ct systems and is reportable under 21cfr1003.Siemens will initiate a voluntary recall regarding this issue.
Event or Problem Description
Siemens has identified that in very rare cases (only one single occurrence worldwide has been reported to date) the x-ray dose is incorrectly recorded as a negative value.Somatom flash and drive ct systems with vb10a and later versions are potentially affected.The following conditions must be fulfilled to reproduce this issue: if the filter "mlmoveablefilter2bodywedge" is used in a spiral scan and this scan is combined with other scans in a workflow (chronical) and the option "care kv grouping" is set to "on", our system copies internally parameters from one spiral into the other spirals.If there are spirals without using this filter, the system detects this as an error and marks the copied ctdi value in the second spiral with a negative sign.Afterwards the sum for this calculation is not correct/results in a negative ctdi.There has been no incident of patient injury or other adverse event associated with this issue.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10968091
• Report Number: 3004977335-2020-39091
• Device Sequence Number: 16725134
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1