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

Model Number	10432915
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of an issue reported by the siemens healthineers customer service engineer (cse) who was performing preventative maintenance of the magnetom skyra (de) system.While performing the patient table horizontal drive check from the bottom of the table, and while reaching up into the mechanism, the cse felt a sharp pain in his neck.The cse described the pain as extending from his neck down his back and to what felt like the back of his heart.Initially, siemens healthineers was informed that the cse was treated with physical therapy; however, new information was provided on july 24, 2024, that stated the cse underwent surgery.The nature and extent of the cse's injury and type of surgical procedure performed are unknown as of the date of this report.It was stated that the cse is already feeling much better three weeks post-surgery.As of the date of this report, the event reported is seen as a work error and we currently have no indication of a product malfunction.The investigation is ongoing.
Additional Manufacturer Narrative
H6: siemens healthineers has initiated an investigation of the reported event.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported event.It was stated in the investigation that the injury was caused because of the nature of the workflow that put the customer service engineer in a difficult working position.The conditions of the workflow are to lay down on the floor and remove the screws to get the cover off.Some of the screws on the table have loctite applied to them and these screws strip easily which makes it very difficult to remove them in an awkward physical position.The root cause analysis and possible measures are handled via the environmental health and safety (ehs) process.No further details were provided by the ehs team.

• Brand Name: MAGNETOM SKYRA (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: 20046006
• Report Number: 3002808157-2024-00012
• Device Sequence Number: 20816561
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: (01)04056869006703
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: Other
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/09/2025
• 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: Required Intervention
• Patient Sex: Unknown