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

Model Number	11060815
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a patient injury involving the magnetom vida system.Injury information was provided for two patients.Patient 1 sustained a second degree burn on the left breast (size approx.5 cm x 2 cm).Although requested, no information about medical treatment has been provided for this patient.Patient 2 also sustained a second degree burn on the left breast (size approx.5 cm x 2 cm).Within 24 hours following the biopsy, a blister appeared at the biopsy site and subsequently evolved into a skin ulceration.The patient underwent a lumpectomy five days after the biopsy.Although requested, no further information about medical treatment of the burn was provided.Additionally, it was stated in the provided questionnaires that there were five occurrences in total.No injury information has been provided for the other three patients as of the date of this report.Based on the information received as of the date of this report, siemens healthineers cannot exclude a serious injury occurred.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.

• Brand Name: MAGNETOM VIDA
• 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: 24613648
• Report Number: 3002808157-2026-00006
• Device Sequence Number: 18687414
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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