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

Model Number	10432914
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was initially informed by the yamanashi prefectural police that a patient complained to them that they suffered burns on their back.The date of the event was initially reported as 2023-07-21.The police were inquiring about the event with siemens healthineers.The severity of the patient¿s burns was not specified by the police during the initial inquiry.Additional information received by siemens healthineers on 2023-08-02 revealed the patient incident occurred on an unknown day during (b)(6) 2020.It was further clarified that the customer facility did not contact the local siemens customer service organization at the time of the incident.At this time, additional information regarding the severity of the injury, medical intervention, current patient status, have been requested.As the date of this report, siemens cannot exclude with absolute certainty that a serious injury occurred.
Additional Manufacturer Narrative
B3: exact date of event is unknown.The event reportedly occurred during (b)(6) 2020.E1: the reporting facility contact phone number is (b)(6).H3, h6: siemens healthineers has initiated an investigation of the reported event.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Additional Manufacturer Narrative
Siemens healthineers has completed the investigation of the reported event.It was initially communicated that an incident involving an mri system magnetom aera (serial no.(b)(6) ) and there might be a serious injury associated with this incident.Per the initial complaint report from (b)(6) 2023 it was stated that a patient sustained burns on their back.The severity of the burns was not specified.The yamanashi prefectural police was investigating the incident and has contacted the hospital and siemens healthineers japan to do so.Siemens healthineers became aware of this incident when the yamanashi prefectural police contacted us.To investigate this incident, siemens healthineers requested more detailed information and data.Per the additional information from august 2, 2023, it was clarified that the incident happened in (b)(6) 2020, over 2.5 years before siemens healthineers was made aware of the incident.Due to the month and year of the event, there was no save log available for an investigation.Furthermore, no patient details were made available.The severity of the injury or any possible medical treatment remains unknown.However, siemens healthineers was informed by the local japanese police that the patient was examined while wearing wet clothing.Additionally, the system is serviced by customer service engineers (cse) on a regular basis.The system was last checked before the incident on (b)(6) 2020 during maintenance and first after the incident on 2020-12-09 for maintenance and evolve after the incident.No abnormality was found with the system.In summary no hardware or software problem was found, which would explain the reported burns of the patient¿s back.The root cause for the complained burns could not be determined with absolute certainty.Since the police stated that the patient was examined in wet cloths, it is conceivable that electric current loops could have formed and may have caused the burns on the patient¿s back.The magnetom family / operator manual ¿ mr system / syngo mr xa30 explicitly warns the user about the formation of electric current loops.To avoid the formation of current loops the user must ensure that the patient does not wear clothing that is wet or dampened by perspiration and ensure sufficient ventilation.H6: codes were updated based on additional information received during the investigation.

• Brand Name: MAGNETOM AERA
• 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 19335 ; 4843234198
• MDR Report Key: 17465633
• Report Number: 3002808157-2023-00008
• Device Sequence Number: 7236912
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 10432914
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 05/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown