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

Model Number	11060815
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Siemens healthineers was notified of an issue and a potential injury associated with the magnetom vida system.It was stated that the tui handle broke as a technician attempted to pull the table out of the docking station.As the handle broke, the technician lost balance, fell backward, and landed on the floor.The technician stated the fall resulted in radiating back pain.Although requested, detailed information regarding the severity of the injury, medical intervention provided, and current health status of the technician has not been provided to siemens healthineers as of the date of this report.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) has investigated the reported event.Additional information was requested via teams regarding the current health status of the injured technician.Siemens was informed that the technician who fell backward sustained nerve damage to her back.She is still experiencing pain from time to time.At this time, no specific medical treatment has been reported other than taking time off work to rest and recover.Our technical experts have thoroughly examined the reported issue and reached the following conclusion: the handle extends beyond the contour of the patient table, making it the first component to come into contact during collisions.Given the substantial mass of the patient table and the additional weight of the patient, any impact generates a significant impulse force.The current attachment points of the handle are not designed to absorb such forces repeatedly.To address this issue, the design of the handle has been modified so that it remains within the frame structure of the table.This adjustment will significantly reduce the likelihood of accidental impacts.Additionally, the bracket structure has been reinforced to enhance overall stiffness and durability.Siemens replaced table user interface with sensor (material no.11293427; serial no.(b)(6).The complaint has been closed.

• 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: 24627294
• Report Number: 3002808157-2026-00007
• Device Sequence Number: 15627850
• Product Code: LNH
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K252838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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