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

Model Number 10432914

Device Problem Excessive Heating (4030)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/21/2020

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.It was reported that a male patient suffered second degree burns (approximately 15mm in diameter) to both inner thighs.The patient received medical treatment by the medical team.No further information regarding the type of treatment was provided.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.There was no serious injury associated with this issue.It was reported that a patient suffered 2nd degree burns (15 mm blisters) on both upper inner thighs.The medical team caring for the patient performed medical treatment.As no further information regarding the medical treatment has been received a report of the event was submitted in the abundance of caution.Siemens experts analyzed the images generated during the patients' examination.The complete examination of the patient's lower extremities lasted 32.6 min with an active scanning time of 26.4 min.No abnormality was found which would indicate a system malfunction.The measurement was performed in the first level (fl) 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 21% 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 12.5 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 a siemens service engineer and no deviations were found, that could have led to the burn.No hardware or software problem was found that would explain the reported blisters on the patient's upper inner thighs.It is visible on the mr images that the thighs were touching each other.There was no pad between the upper thighs.Therefore, the root cause for the burns is a rf current loop that may be generated when parts of the patient's body touch.This effect and the preventive measures are described in the magnetom family operator manual - mr system syngo mr e11 (pages 19 - 21).Print no.Mr-02501.621.01.02.02.The instructions given in the operator manual, regarding correct patient positioning should always be followed 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; and, to ensure this distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.There is no indication of any malfunction of the system.No further actions are planned by the manufacturer as no system malfunction was identified.

• 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: 11038136
• MDR Text Key: 222359136
• Report Number: 3002808157-2020-58550
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K191050
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other