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

Model Number	10432914
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the investigation is ongoing.The root cause of the issue has not been identified.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Siemens healthineers was notified that the magnetom aera docking station was difficult to move while a patient was on the table.It was stated that the mri technician was injured due to this issue.Additional information regarding the mri technician¿s injury was requested from the customer.Since the severity of the injury is unknown, this event was reported.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported problem.Siemens requested additional information regarding the technologist¿s injury from the customer; however, no additional information was provided to our specific questions.Siemens was not made aware of a serious injury associated with this event.A siemens customer service engineer (cse) visited the site to identify an issue with the patient table¿s maneuverability.The table was undocked, and all functions were tested, including vertical and horizontal movement, brake engagement, clutch, and emergency release.All tests were completed successfully.The table was also tested with a person weighing 230 lbs., and no issues were observed during movement.However, the front left handle was found to be missing, which made maneuvering the table more difficult.During daily use the operator personnel should have been able to notice the deterioration of the table handle and to contact the siemens service organization early enough to exchange the defective table handle to prevent patients/staff from hazards.Therefore, a death or serious injury is very unlikely in case of reoccurrence.During the cse site visit, no further information was provided regarding the technologist¿s injury.As a result, we are unable to confirm the injury or assess its severity.Additionally, no save log was created or provided for further analysis.Therefore, no further investigation is possible.To solve the issue at the customer site, the missing table handle was replaced.Since the issue has already been fixed at the customer site, siemens has closed this complaint.

• Brand Name: MAGNETOM AERA
• 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: 22381866
• Report Number: 3002808157-2025-00014
• Device Sequence Number: 12834440
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 10432914
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 03/31/2026
• 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