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

Model Number 7740769

Device Problem Inadequate User Interface (2958)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

Technical investigation showed streak artifacts during pediatric head scans.This kind of artifact is typically caused by patient motion.The customer stated they had not used the recommended head holder and the patient's head was directly on the patient table during the scan, which caused the artifacts.The customer was advised to use the head holder for every head scan to reduce motion during scans, especially for pediatric scans.Considering the investigation results, there is no further corrective action initiated.

Event Description

The customer informed siemens on june 30, 2017 of a pediatric head scan that was repeated due to artifacts, which occurred on (b)(6) 2017.It was reported during investigation that there were three (3) other similar occurrences with pediatric patients that received additional x-ray dose also with head scan protocol on different dates.However, there is no report of injury to a patient.This reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6752790
• MDR Text Key: 81418263
• Report Number: 3004977335-2017-86282
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122471
• 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: 07/28/2017,06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7740769
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2017
• Distributor Facility Aware Date: 06/30/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2017
• Date Manufacturer Received: 06/30/2017
• 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