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

Model Number 8098027

Device Problem Improper Device Output (2953)

Patient Problem Death (1802)

Event Date 02/26/2018

Event Type  Death  

Manufacturer Narrative

Investigation revealed that the patient died from an aortic issue that required immediate surgery apart from the diagnostic issue with the ct, which was confirmed by the patient's physician on (b)(6) 2018.The physician reported that the thoracic surgery could not be performed at that hospital facility and in his opinion the patient would not have survived the length of time it would have taken for a facility transfer.Analysis of logfiles associated with the reported issue showed that the patient table was blocked by external forces during examination, which caused the system to reset and placed the dms in a state of error that required a reboot.The reboot was not completed as requested by the system, which caused the dms to malfunction and produced the ring artifacts in the images.A service engineer was on-site on march 1, 2018 and performed a dms check that did not show any failures.No general product issue can be identified and considering this, no further measure is required.

Event Description

It is reported that ring artifacts began showing in images from the somatom definition as on (b)(6)2018.On (b)(6) 2018 the operator rebooted the system, performed a checkup and the system then functioned normally.On february 27, 2018 siemens was notified that on (b)(6) 2018 the examination of an intensive care patient could not be completed due to ring artifacts showing in the images and the images could not be used for diagnosis.On february 28, 2018, siemens was notified that the patient died on (b)(6) 2018.(b)(6).

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 7374990
• MDR Text Key: 103609613
• Report Number: 3004977335-2018-19492
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143400
• 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: 03/27/2018,02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Distributor Facility Aware Date: 02/28/2018
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR