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

Model Number 10430603

Device Problems Use of Device Problem (1670); Application Network Problem (2879)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).A siemens technical investigator investigated the reported issue and came to the conclusion that the missing data in the first evaluation were clearly indicated by the quality chart.The alleged misdiagnosis of the first results has been classified as a use error.The quality control image indicated clearly that there was no image information after 25 scan seconds.Each result image contains a warning that the pre-calculated evaluation results shall only be used after checking the quality control images.No general design issue was identified.

Event Description

It was reported to siemens that a patient with suspected stroke was examined by a brain ct with the somatom definition force system without contrast medium (ct perfusion and cta of the cerebral arteries).The data from the ct scan were immediately sent to the pacs via the option "autotransfer".The post processing application "ct neuro perfusion" uses this data, does some pre-calculations and generates an initial evaluation of the data in the background.Network problems in the hospital occurred when the data was sent to the pacs.The network problems apparently resulted in the data traffic interruptions to the pacs.These network problems apparently resulted in the last 20 seconds of the image data-block missing.Thus, the evaluation did not fully reflect the patient´s condition at the first attempt to perform the post-processing job.The neurologist who first evaluated the images came to conclusions based on incomplete image data.The neurologist diagnosed that the patient has left-sided parietal ischemia that is mostly core (i.E., brain tissue with irreversible damage).Obviously, the pre-calculations done by "ct neuro perfusion" were accepted, even if they were based on an incomplete data set.There are special quality assurance charts in place to enable the user to identify missing data.Regardless of the results of the perfusion test, the neurologist decided not to treat with the thrombolysis due to the advanced age of the patient ((b)(6) years) and the time elapsed since the beginning of the symptoms.Two hours later, the hospital staff noticed that the application "ct neuro perfusion" provided a new, updated version of the same test (automatically generated by the system) with contradictory findings.The dataset was completely available meanwhile.This time it seemed that there was a left parietal ischemia most of which was penumbra (i.E.Brain tissue with potential to improve after the vascularization).Also, there was no cta blockage of the carotid arteries.No patient injury was reported, no rescan took place and incorrect therapy treatment was not initiated.This report is being conservatively submitted based on misdiagnosis following the ct scan.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: 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 ; 6104486484
• MDR Report Key: 8822384
• MDR Text Key: 152066057
• Report Number: 3004977335-2019-87658
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR