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 Codes	Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a patient event during an mri examination on the magnetom skyra system.The patient stated that she was violently bounced on the patient table during a diffusion scan.The patient went to a chiropractor and x-rays were taken.The customer facility does not have any additional information regarding the patient¿s health status, nor do they know whether medical treatment/intervention was provided after the x-ray examination.
Additional Manufacturer Narrative
H3, 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
Additional information regarding patient.Siemens healthineers has completed the investigation of the reported event.It was initially communicated that the patient stated that she was violently bounced on table during a diffusion scan.The patient went to a chiropractor, had x-rays, and her doctor stated that her neck was misaligned.The customer does not have any further information regarding the patient's state of health, nor does he know whether medical treatment or intervention was necessary after the x-ray examination.The complained issue was investigated.The patient table was checked as it had shown switch error and hydraulic lock messages.The siemens healthineers customer service engineer (cse) provided the information that when the table is raised to home position, it floats back down and won't stay up.During troubleshooting, the power stage (material.No.10433511) and the hydraulic cylinder-vertical lift (material.No.10591691) were replaced.Unfortunately, they were not sent back as complaint parts, therefore could not be analyzed.The system was tested several times with heavy phantoms and persons on the table and was working as specified.Unfortunately, no additional information has been provided to define the patient¿s statement of being "violently bounced" and in which way the patient was bounced during the diffusion scan.This complaint has been closed.H6: health effect ¿ clinical code was updated based on the additional information.
Event or Problem Description
***additional information*** the patient went to a chiropractor, had x-rays, and her doctor stated that her neck was misaligned.The customer does not have any further information regarding the patient's state of health, nor does he know whether medical treatment or intervention was necessary after the x-ray examination.

• 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., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18941575
• Report Number: 3002808157-2024-00005
• Device Sequence Number: 18238056
• Product Code: LNH
• UDI-Device Identifier: 04056869006703
• UDI-Public: 04056869006703
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 10432915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female