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

Model Number 10432914

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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 following examination on the magnetom aera system.A patient felt heat on the inner side of her legs during hip exam.Patient pressed the intercom button to inform the tech, however, the tech did not respond.According to the patient, she developed blisters in between her legs after the exam.Despite several requests for additional information, no information was provided to siemens regarding the size and severity of the blister or area of redness.Additionally, no information was provided regarding any medical intervention necessary or healing complications.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Our experts analyzed the images generated during the patients' examination.The complete examination of the patient lasted 32.6 min with an active scanning time of 28.8 min.The alarm ball was pressed after 9.3 minutes.Measurement was aborted immediately.No abnormality was found which would indicate a system malfunction.The measurement was performed in the first level operating mode.The sar values were within the limits defined by the mr safety standard (iec 60601-2-33), i.E.The maximum applied sar was 49% of the first level mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore the patient absorbed 49.1 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The system was checked by the cse and found to be in specification.In summary no hardware or software problem was found which would explain the reported burn of the patient.The patient had pressed the alarm ball early.The patient should have been examined carefully afterwards.Changing the operating mode to normal mode (nm) and providing spacer cushions to the patient to be placed in between the thighs would have been appropriate.The described issue - burns on the inner thighs - is well known.Root cause is an rf current loop (skin-to-skin-contact between the inside region of both thighs).This effect is described in the magnetom family operator manual - mr system syngo mr e11 (p.19ff).Please always follow the instructions given in the operator manual, regarding correct patient positioning in order to avoid such incidents in the future.Always position the patient so that the patient's arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm).Ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering.To ensure this distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.

• Brand Name: MAGNETOM AERA
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8764836
• MDR Text Key: 150157245
• Report Number: 3002808157-2019-85551
• 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,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10432914
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other