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

Model Number 8098027

Device Problems Display or Visual Feedback Problem (1184); Device Issue (2379)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Siemens conducted a thorough evaluation of the reported event.The investigation concluded that by performing a new checkup of the system, a gain-calibration was done which optimizes the function of the modules in the detector.The dicom images that were provided show that the mentioned artifacts are clearly visible so that the risk of a misdiagnosis can be excluded.According to all of the information provided, this solved the issue.The customer/user of the system is reminded to perform daily check ups of the system as recommended in the user manual.No systematic product issue was detected, and no further measures were required.

Event Description

Siemens was made aware on (b)(6) 2018, that during a patient procedure using the somatom definition as, a (b)(6) year old male patient got rescanned due to artifacts appearing in the ct scan.The artifacts are described as a dark rotating shadow.The patient was rescanned with additional x-ray dose.There was no negative impact reported, no further injury to the patient.This event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; advanced therapy; siememenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS; 40 liberty boulevard; ms-65-1a; malvern PA 19355 9998
• Manufacturer Contact: mary stamer ; 40 liberty boulevard; ms-65-1a; malvern, PA 19355-9998 ; 6104486485
• MDR Report Key: 7527419
• MDR Text Key: 108721660
• Report Number: 3004977335-2018-26577
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/18/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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): Other
• Patient Age: 6 YR
• Patient Weight: 20