MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM AERA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432914

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Sensitivity of Teeth (2427); Patient Problem/Medical Problem (2688)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Additionally, the patient stated: "i do not believe the mri was the root cause of my severe pain and broken tooth.The condition in my knee pre-existed and was aggravated by the mri.In my case, there was no reason to believe i would encounter this pain during the mri procedure (e.G.No metal in the knee etc.} and the mri created a condition for negative or adverse consequences." siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom aera system.A patient reported directly to the health canada authority that during an mri examination of his knee he felt severe and unexpected pain in his knee.The patient clenched his teeth to tolerate the pain and while doing so he broke a tooth.The broken tooth required dental surgery.The customer was unaware of any issue at the time of the event.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the dicom images, save log and quality assurance tests did not indicate a system failure or malfunction and no non-conformity was identified.After becoming aware of this event siemens requested dicom images, savelog, and quality assurance test results for a deeper investigation.According to the dicom images evaluated by our inhouse radiologist, it can be stated that there is no visible reason for this pain increase (e.G.Metal implants, other foreign objects).A system qa on 2020-01-17 did not show any deviations.The customer was not aware of this issue, i.E.The patient had not stopped the examination.There is no indication of a system malfunction and it was concluded that the system is working as specified.The pain increase of the patient may have been caused by the positioning of the patient for the mr examination together with the pre-existing knee issues.The magnetom family operator manual, syngo mr e11 (print no.Mr-02501.621.01.02.02) states in chapter 5.4.1: - show the patient how to activate the patient alert by pressing the squeeze bulb.- ensure that the patient holds the squeeze bulb in his/her hand during the measurement.If these safety precautions are followed, the patient can alert the operator in case of experiencing discomfort.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.

• Brand Name: MAGNETOM AERA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 9606942
• MDR Text Key: 177345405
• Report Number: 3002808157-2020-15561
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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: 10432914
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention