MAUDE Adverse Event Report: SIEMENS HEALTHINEERS GMBH SOMATOM DEFINTION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8098027

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is on-going and a supplemental report will be submitted upon completion should further information become available.

Event Description

It was reported to siemens on (b)(6) 2018, that a malfunction occurred with the somatom definition as it was used to perform a ct head examination on a (b)(6) patient.After the head ct scan of the patient was completed, the physician diagnosed the results of the ct scan to indicate the occurrence of a cerebral infarction on the left side of the patient's brain.The patient was then sent to a specialty pediatric hospital for further evaluation and treatment.The specialty pediatric hospital completed an additional mri examination on the patient, and concurred that the initial diagnosis was incorrect, and the patient had a normal mri scan.Based on this second diagnosis, the initial physician stated that the somatom definition as had malfunctioned and showed artifacts that had been interpreted as a cerebral infarction.The investigation is on-going.This event occurred in (b)(6).

Manufacturer Narrative

H10: siemens completed the technical investigation of the reported event.The root cause of the reported event could not be determined.The customer complained about a dark region, interpreted as a cerebral infarction, in the left side of the pediatric head scan.Based on four images provided to siemens, it was determined that this dark region was not likely an image artifact.Siemens was not able to assess if the dark region is a normal anatomical variation or if there are pathologies that do not show up in mr.Although requested, additional information from this case was not provided.Siemens requested that in the event of reoccurrence, the customer provide raw data, preferably complete image volume in thin slices (complete dicom series of studyimages) and a screenshot where the perceived artifact is marked.B1, b2, h1: the initial complaint (as initially reported) was both an adverse event (incorrect diagnosis) and product problem.D10.File attachments.

• Brand Name: SOMATOM DEFINTION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; advanced therapy; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 7472244
• MDR Text Key: 106867209
• Report Number: 3004977335-2018-26066
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K103127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2018,04/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 9 YR