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

Model Number	10684332
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
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 an adverse event occurred while operating the magnetom avanto dot system.During table movements, a patient´s finger tip was caught between the tabletop and trolley.As a result, the patients finger tip was severed.The patient was evaluated in the emergency room and surgery was performed to reattach the severed tissue.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.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The correct function of the patient table was checked, no mechanical damages could be seen on the photos and no patient table error was recorded in the event log from 14.10.2020 - 17.10.2020.Therefore, it was concluded that the patient table worked correctly as specified and the error was caused by an operator error.The operator manual magnetom avanto, page a.2-14, provides clear instructions to carefully monitor the patient during table movements.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• 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
• MDR Report Key: 10747159
• Report Number: 3002808157-2020-51590
• Device Sequence Number: 3125512
• Product Code: LNH
• UDI-Device Identifier: 04056869006635
• UDI-Public: 04056869006635
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 10684332
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: Required Intervention