MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM SEMPRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10840815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.At this time, no system malfunction has been identified.All related test reports and savelogs are currently under analysis.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom sempra system.During a pelvis scan, a (b)(6) year old female patient had difficulty breathing.The patient alerted the operator and the scan was stopped.The patient was provided oxygen but was still having difficulty breathing and collapsed and became unconscious.The patient was transferred to the cardiac icu for further management.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.During investigation, all system qa tests were within specification.Sar values could be calculated and recorded by the mri system and they did not exceed the limitations (otherwise the measurement can't be performed and reported error message), which means the mri system wasvworking normally.Stimo values could be calculated and recorded by the mri system and they did not exceed the limitations (the stimo value was very little at that time).Furthermore, the system is equipped with a squeeze ball and intercom to make sure the patient is monitored during the examination.Based on the information above, there was no system malfunction in this issue.The system works normally and no similar issue has been reported.There is no explanation for the temporal coincidence of the occurrence of the reported health problems of the patient and the mri scan.

• Brand Name: MAGNETOM SEMPRA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave. 2nd; hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12613760
• Report Number: 3004754211-2021-00169
• Device Sequence Number: 16481348
• Product Code: LNH
• UDI-Device Identifier: 04056869044521
• UDI-Public: 04056869044521
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K183221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 10840815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/06/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown