MAUDE Adverse Event Report: Siemens Healthineers AG MOBILETT Elara Max; System, X-Ray, Mobile

Model Number	11107444
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of an event involving an mobilett elara max system.It was communicated that a member of the hospital staff sustained an electrical shock when they plugged the system in.The person was admitted to the emergency room for examination; however, details regarding the clinical outcome are unknown to siemens as of the date of this report.This information has been requested by siemens.
Additional Manufacturer Narrative
H6: initial actions (corrective and/or preventive): there is no general issue identified in the field that requires immediate actions.Manufacturer's preliminary results and conclusion: the investigation is ongoing.The root cause has not yet been identified.A supplemental report will be submitted to the fda upon receipt of reportable information and/or the completion of the investigation.

• Brand Name: MOBILETT Elara Max
• Common Device Name: System, X-Ray, Mobile
• Manufacturer (Section D): Siemens Healthineers AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): Siemens Healthineers AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; +1(484)323-4198
• MDR Report Key: 50609921
• Report Number: 3004977335-2026-00156
• Device Sequence Number: 16129943
• Product Code: IZL
• UDI-Device Identifier: 04056869154992
• UDI-Public: (01)04056869154992
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K182639
• 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
• Report Date (Section B): 09/04/2026

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: 11107444
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown