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

Model Number	10684331
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/25/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.Further information received from the customer site states that the incident was not caused by the equipment; but was caused by their protocol/procedure.Additionally, it was reported that the patient passed away some time after the incident.However, it was reported that the patient passed away as a result of a previous condition and not as a result of the laceration.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 avanto dot system.It was stated that an iron disk used to immobilize organs after surgical intervention was attracted to the magnet and injured the patient.The patient suffered a laceration to the jaw.The severity of the injury or applied medical intervention is not known.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.The root cause was determined to be a user error.It was stated that an iron disk used to immobilize organs after surgical intervention was attracted to the magnet and injured the patient.The patient suffered a laceration of the jaw.As siemens did not receive any information in respect to the severity of the injury and applied medical intervention, an in-doubt reporting was prepared.Furthermore, siemens received information from the customer that a system malfunction can be excluded.The customer himself considered the issue as a user error.In addition, siemens received information that the patient died some time after the procedure.The customer investigated this issue and determined that the base of the pathology of the patient was a massive stroke.The injury (laceration) was not related to the death.The clinical history of the patient mentioned stitches, however, it didn't described the number of stitches.

• Brand Name: MAGNETOM AVANTO DOT
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12688097
• Report Number: 3002808157-2021-98611
• Device Sequence Number: 17203000
• Product Code: LNH
• UDI-Device Identifier: 04056869006628
• UDI-Public: 04056869006628
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 10684331
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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
• Patient Sex: Unknown