MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM SOLA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11291455
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.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 a malfunction occurred while operating the magnetom sola system.During a cardiac study, the user reported that the system hung up, and the study had to be repeated.It is not known if additional contrast was administered.At this time, we are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has attempted an investigation of the reported event.It was stated in the complaint, that the system crashed during a cardiac study with contrast agent.The only way to continue was restarting the whole system which made it necessary to reinject contrast.The data available in this potential complaint does not contain sufficient information to conduct an investigation.Siemens was made aware on november 4, 2020 that the system received a software update and the savelog that is essential for the investigation is not available.

• Brand Name: MAGNETOM SOLA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 10717390
• Report Number: 3002808157-2020-49136
• Device Sequence Number: 3245743
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: 04056869164809
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K192496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1