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

Model Number	11410371
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom altea mr system.It was stated that a patient reported a skin burn seven days after an mr scan.The patient noted pain and blisters on the index knuckle and left forearm when he got in the car afterwards.Later it was diagnosed that the patient suffered a full thickness burn on the left forearm and a partial thickness burn on the right index knuckle.Both burns have a size like a knuckle.It was stated that the points of burn were touching each other during examination.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported event.Siemens healthineers experts analyzed the sar values based on the rfswd history list logfile because no dicom images were provided.However, it is unclear if the correct file was used, as the information in the logfile and the information from the questionnaire are not identical (logfile: 110 kg, 179 cm, feet-first examination / questionnaire: 100 kg, 180 cm, head-first examination).The sar values were below the limit of 2 w/kg during the whole examination.The complete examination of the patient¿s biceps lasted 31.6 min with an active scanning time of 23.9 min.No abnormality was found which would indicate a system malfunction.The complete measurement was performed in the normal 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 75.3% of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 34.35 wmin/kg which is 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 found to be in specification except for the ultraflex large 18 coil (material 11134335; serial (b)(6)), which is unlikely to be related to the current incident.The ultraflex large 18 coil was returned to our factory and inspected by our experts.They found several anomalies (e.G.Foramen was cracked, antenna b33/34 broken) but all safety relevant functions work as specified.In summary no hardware or software problem was found which would explain the reported burns on the patient¿s right index knuckle and left forearm.It was stated in the provided questionnaire that the patient¿s right index knuckle was touching the left forearm.Therefore, the root cause for the burn is a rf current loop which may generated when parts of the patient¿s body touch.This effect and the preventive measure are described in the magnetom family operator manual ¿ mr system and coils syngo mr xa51.Instructions given in the operator manual should always be followed including the 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 distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.This complaint has been closed.No further action is deemed necessary.

• Brand Name: MAGNETOM ALTEA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 20046046
• Report Number: 3002808157-2024-00014
• Device Sequence Number: 8043662
• Product Code: LNH
• UDI-Device Identifier: 04056869230726
• UDI-Public: (01)04056869230726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: 11410371
• Device Catalogue Number: 11410371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown