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

Model Number FORCE

Device Problem Defective Component (2292)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, pt came to ed/ct from the ccu for a "gated cta chest".Exam was started with a topogram and premonitoring images of contrast enhancement, at 150hu the scanned would trigger the imaging to begin.Imaging would start and without notification or error the scan aborted.The same process was followed a total of three times; injecting contrast, administering radiation through imaging and scan aborting.After three consecutive failures, the pt was removed from the scanner without any usable images.Siemens field service engineer had been on site to address the issue of aborted ct scan.After evaluation of the scanner by both on line support and on site engineer the scanner was deemed operational as it had passed all the necessary tests required to resume operations.On (b)(6) 2019, the same pt that had failed imaging on (b)(6) 2019 returned to ed/ct from the ccu for a "gated cta chest".The same process began with a topogram and premonitoring images of contrast enhancement, at 150hu the scanner would trigger the imaging to begin.Imaging started and without notification or error to technologist the scan aborted.At this time the pt was removed from the scanner and returned to the ccu.Immediately a call was placed to service and the scanner was taken out of use by the physician in charge who deemed the scanner unusable.Of interest is that on this occasion a "guardian" notification was sent to the "up time" service center of siemens stating that an error had occurred.In fact the "b" tube of the scanner was no longer working as intended.Although "up time" was notified of an error, no message ever appeared to the scanning technologist.

• Brand Name: SOMATOM FORCE CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 8496681
• MDR Text Key: 141452374
• Report Number: MW5085672
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 107