MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM AERA; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number 1043488089

Device Problems Poor Quality Image (1408); Use of Device Problem (1670)

Patient Problems Breast Cancer (1759); Patient Problem/Medical Problem (2688)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

It was reported to siemens that the magnetom aera system does not produce good quality images.A relapse of a breast tumor was not captured during an mri exam using the 4-channel breast coil.The patient had to undergo a surgery.The reported incident occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.According to our technical expert, the save log analysis does not provide any evidence of a technical problem which could have resulted in the bad image quality.Furthermore he compared the customer protocol to the siemens default protocol for the 4 channel breast coil "t1_fl3d_tra_nonfatsat_1+5".Several deviations from our standard protocol have been detected.Please refer to the safety instructions in our manual (syngo mr e11 - gebrauchsanweisung - scannen und nachverarbeitung - mr-05010g.630.19.02.01) "use of inappropriate protocol settings! wrong diagnosis due to insufficient quality of the parameter values.Ensure that the quality of the parameter values are sufficient.Therefore use only siemens protocols." according to our service engineer the customer used additional coils: bo1-3; and sp1-4 with the breast coil (2bl; 2br) excepting localizer and first stir_tra protocol.The consequences are noisy images, folding artifacts etc.The additional coils were selected manually by the customer (protocol setup- coil select mode: on-coil memory) with the explanation "to gain more signal".The setting of the dynamic protocol after application of the contrast agent (t1_fl3d_tra_nonfatsat_1+5_p2) has a suboptimal setting: 1 average, 512x512 resolution and slice thickness of 2.5 mm.The entire protocol constellation is considered insufficient for good image quality.The expert also assumes that with the fov of 380 mm, the phase oversampling of 20% used is not sufficient.Our medical officer investigated the images of two female patients and provided the following conclusions.Patient 1: examination of the images provided shows that the patient was positioned inappropriately.The images clearly show that the breast is strongly compressed and "folded".In this way it is not possible to show all parts of the breast, since the breast tissue is partially outside the breast coil.The size of the canned coils can be adjusted depending on the female patient.Patient 2: the images show, that not a sufficient amount of contrast agent has been applied.There is no contrast agent in the contrast -enhanced dynamic series.If the contrast agent had been used, the images would have been of adequate quality and the diagnose could probably have been made correctly.Both our technical and medical experts assume that the images would have been suitable for diagnosis if contrast agents had been administered and the patient had been positioned correctly.We strongly recommend optimizing the protocols used and the workflow.A detailed description can also be found in the documentation (magnetom family - gebrauchsanweisung - 4 ch bi breast / 16 ch ai breast - syngo mr e11 - mr-04010g.623.34.02.01).The system works as specified.Therefore, 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: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• MDR Report Key: 10320362
• MDR Text Key: 219529440
• Report Number: 3002808157-2020-38264
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (y/n): N
• PMA/PMN Number: K163312
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1043488089
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other