MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM VIDA (DE); SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11060815
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a patient injury while undergoing an examination with the magnetom vida system.The patient felt a burning sensation on their head during the examination which included a head/neck 20 coil.The patient had put her stole underneath her head during the examination.The patient¿s hair was burnt, and a yellow mark was visible on the head coil.As of the date of this report, additional information is not available.It is unknown if the patient sustained injury.Additional information regarding the event and the patient¿s health status has been requested.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A root cause has not been identified.A supplemental report will be submitted upon completion of the investigation if additional information becomes available.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported event.It was stated in the investigation there was no serious injury associated with this issue.It was stated that a patient pressed the squeeze ball during an examination to report a burning sensation on the right side of her head.The patient sustained a minor skin injury/superficial blister on the right back of the head and burnt hair.In addition, the used head/neck coil showed light yellow discoloration / burn marks after the examination.The patient's burn was treated with topical ointment and the patient recovered well.Our experts analyzed the images generated during the patient¿s examination.The complete examination of the patient¿s head lasted 12.8 min with an active scanning time of 8.8 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 46.7 % 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 9.04 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The system and the rf coils used were checked by our service engineer and found to be within specification.The head/neck coil used during the examination was used on multiple other patients in the meantime, and no further heating incidents occurred.The sar values were below the limit of 2 w/kg in normal operating mode during the whole examination.In summary no hardware or software problem was found which would explain the burn on the patient's head.The patient had used her stole as a cushion under her head.The provided pictures of the stole showed that it had several burn marks and holes.In summary no hardware or software problem was found which would explain the burn on the patient's head.The patient had used her stole as a cushion under her head.The provided pictures of the stole showed that it had several burn marks and holes.

• Brand Name: MAGNETOM VIDA (DE)
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; 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.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 22025677
• Report Number: 3002808157-2025-00007
• Device Sequence Number: 12546654
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/02/2025

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: 11060815
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 10/02/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown