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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: a facility contact name was not provided for reporting.H3, h6: the investigation is ongoing.The root cause 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 skyra magnet ruptured after the system quenched.Consequently, helium entered the examination room.There was significant damage to the examination room, control room, and the waiting area.According to the information received from the siemens healthineers customer service engineer (cse), the helium compressor stopped working and the hospital technician requested a third-party company to repair the system.Some hours after the third-party company visited the site, the system quenched.The exact circumstances are still under investigation.Although there were no injuries associated with this issue, serious injury cannot be excluded in the case of reoccurrence.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported event.The maintenance service contract between siemens healthineers and the hospital for the system expired in march 2023.Since then, the hospital has not made any further service requests to siemens healthineers.In addition, since july 2022 the hospital mandated a 3rd party service organization which was not approved by siemens healthineers.According to the available data a significant helium loss was observed during the period of 3rd party servicing which had not been addressed properly.In addition, the coldhead was exchanged under the responsibility of the 3rd party service organization on november 15, 2024, and was conducted at field which is in contradiction to the approved service instructions.These violations of our service instructions and avoidance of appropriate service interactions may have caused this loss of structural integrity of the helium containment system and the resulting system condition.

• 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: 22575848
• Report Number: 3002808157-2025-00015
• Device Sequence Number: 13151487
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: (01)04056869006703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 10432915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown