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

Model Number	10432914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/06/2021
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 following a procedure on the magnetom aera system.A patient reported suffering several blisters on the fingers which spread to the entire hand.The patient was evaluated by two physicians and received conflicting diagnosis.The patient is currently under the care of a physician.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.It was reported that a female patient suffered several blisters on the fingers and spread over the whole hands one day after examination.The patient went to 3 different doctors, a dermatologist, a burn specialist, and a neurologist which requested the exam.A final diagnosis remains unclear.Our experts analyzed the images generated during the patient's examination.The complete examination of the patient's c-spine lasted 50.25 min with an active scanning time of 42.98 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 91.4% of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions, although it was close to the limit.Furthermore, the patient absorbed 50.62 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 our service engineer and found to be operating within specification.No hardware or software problem was found which would explain the reported blisters on the patient's hands.It is most likely that a rf current loop was generated possibly caused by hand contact and amplified by contact with a liquid like sweat or a disinfectant or due to contact with electrically conductive material.This effect and the preventive measure are described in the magneton family operator manual - mr system syngo mr e11 (pages 19 to 21).

• Brand Name: MAGNETOM AERA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13010505
• Report Number: 3002808157-2021-08510
• Device Sequence Number: 14812842
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 10432914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown